Office of Regulatory Affairs

(For Information Only, Field Request is Included with Programs)

Historical Funding and FTE Levels

MISSION

• Achieve effective and efficient compliance of regulated products through high quality, science-based work that results in maximizing consumer protection.
• Conduct investigational and laboratory functions for all of FDA’s major product areas—Foods and Cosmetics, Human Drugs, Biologics, Animal Drugs and Feeds, and Medical Devices and Radiological Products, both before and after marketing.
• Respond rapidly to various types of emergencies, and redirect field efforts during the year among FDA’s different programs to respond to unforeseen emergencies.
• Monitor clinical research and conduct in-plant preapproval inspections to ensure that manufactured products are safe and effective.
• Determine whether import entries comply with FDA regulations.
• Perform outreach to consumer groups, health professionals, states and industry to encourage compliance and safe use of FDA-regulated products. 

The Office of Regulatory Affairs (ORA) field staff support Agency premarket activities by conducting preapproval inspections and laboratory methods validations when requested by program managers responsible for premarket application decisions.  These inspections, which can be of either foreign or domestic establishments, include bioresearch-monitoring inspections of clinical research that is part of premarket applications.   Other premarket inspections are conducted in manufacturing facilities to determine if the facility is able to manufacture the product to the specifications stated in the application.  Inspections are generally performed by consumer safety officers who may be accompanied by a laboratory analyst if review of manufacturing information in the application suggests that additional laboratory expertise is appropriate to assess the facility.  Laboratory method validations are conducted to confirm that the methods described in the premarket application work as described in FDA laboratories.

Field investigators and laboratory analysts conduct foreign inspections for both premarket approval and postmarket compliance purposes.  FDA product center managers select most establishments for inspection.  Postmarket foreign inspections in the drug, biologic, animal drug, and device programs are conducted to assess Good Manufacturing Practices (GMP).  This is consistent with the biennial inspection requirement that Congress requires of domestic manufacturers in these programs.  While Congress mandated that domestic manufacturers be inspected every two years, foreign manufacturers are not included in this requirement.   Beginning in FY 1999, the Foods program, which has historically supported fewer than 100 foreign inspections, began to expand the number of foreign inspections.  About 250 foods foreign inspections are planned for FY 2001.

In addition to conducting regular surveillance over regulated products, the field workforce also serves a critical function when the Agency must respond to emergencies.  The field work force is able to immediately mobilize to investigate reports of product problems including tampering incidents and those due to natural disasters such as hurricanes, floods and earthquakes.   The field workforce is also involved in informing businesses and consumers about FDA-related topics, and in working with state and local agencies to develop programs that make the best use of Federal, State, and local resources in protecting the public health.

To complement the regular field force, the Office of Criminal Investigations (OCI) was established in FY 1992 as part of FDA’s efforts to more effectively investigate instances of criminal activity in the regulated industries.  Agents are given intensive training at the Federal Law Enforcement Training Center in Glencoe, Georgia, and are assigned to offices throughout the country.

Field facilities include Regional Offices, District Offices, laboratories, OCI field offices, and resident posts.   The five Regional Offices are staff offices, which coordinate FDA activities and coordinate with state authorities.   The 19 District Offices serve as offices for investigators and compliance action staff, and are the main control points for day-to-day operations in their assigned areas.  The current inventory of 13 laboratories provide FDA’s basic field product testing capability.  A number of these laboratories serve as specialized facilities for certain types of testing and new regulatory methods development.

FDA also maintains more than 120 resident posts distributed widely across the country.  These are smaller offices, which serve primarily as a base for investigators so that FDA can have investigative staff widely dispersed to respond to emergencies whenever they occur, as quickly as possible to minimize any potential harm.  With all of these Field facilities combined, FDA maintains offices and staff in 49 of the States, and in the District of Columbia and Puerto Rico.

In 1994, the Field Laboratory Consolidation Plan was approved calling for the number of field laboratories to be reduced from 18 to 9 over 20 years.  Under the plan, outdated facilities would be closed and other laboratories would be renovated or relocated.  The plan specified five large total capacity/multipurpose regulatory laboratories and four specialty laboratories.  The five-multi purpose laboratories would be located in Atlanta, GA; Seattle, WA; Jamaica/Queens, NY; Jefferson, AR; and Irvine, CA.  Currently, the Jamaica/Queens construction and Atlanta and Seattle expansions are complete.  The Jefferson, AR, construction is nearing completion, and the second phase of the Irvine, CA, construction is slated for completion in 2003.

REQUESTED INCREASES

(For Information Only, Field Request is Included with Programs)

Pay Increase  + $14,060,000

FDA’s request for funds to cover pay cost increases is vital to the Agency because personnel are so essential to accomplishing its mission.  Pay increases have a major impact on FDA because the Agency is more people-intensive than many other government agencies.  Payroll accounts for over 60 percent of the total FDA budget. This has a significant impact on all activities in FDA, particularly the field.  The costs of the pay increases are necessary to ensure the integrity of the Agency's field labor force for inspections, compliance, and investigational functions.

In order to maintain the level of activities carried out in FY 2001, FDA is requesting $40,000,000 million to cover the cost of the FY 2002 pay raise, annualization of the FY 2001 pay raise, anticipated within grade increases, and one extra day of pay.  ORA’s portion of this increase is $14,060,000.

This increase will enable the field force to keep pace with a growing and more technologically complex and diverse regulatory environment. The field force has been unable to grow to meet the new challenges because the Agency had to absorb the costs of pay increases.

Bovine Spongiform Encephalopathy (BSE)  + $10,900,000 and 98 FTE

• Conduct additional training for Federal and State inspectors on the BSE feed regulation, update them on the current European Union situation, Animal Plant and Health Inspection Service (APHIS) authority and approach, and what to look for and how and when to sample.
• Increase domestic protection by conducting 1,000 more domestic inspections.
• Increase leveraging with State agencies by funding approximately 4,000 contract inspections of feed mills and renderers, and conduct compliance, follow-up, and audit inspections to state contracts.
• Collect and analyze 600 new domestic and 600 new import feed and feed component samples for BSE related contaminants to ensure proper labeling of animal feeds and feed components.
• Provide intensive line entry and label review of an anticipated 175,000 import line entries for use in domestic commerce for the Animal Drugs and Feeds program by expanding import staff by 17 FTE.

Imports and Inspections + $22,000,000 and 83 FTE (Budget Authority   + $7,300,000 and 36 FTE; User Fees   + $14,700,000 and 47 FTE)

Budget Authority

• Increase monitoring of fraudulent drug import activities by increasing criminal investigations and conducting 96 more authenticity analyses of imported drug products.
• Improve safety of domestic drug products by increasing sample analyses of domestic products.
• Improve the safety of imported biological products by increasing the surveillance of imported human tissues and other imported biological products.
• Increase coverage of domestic biological products by conducting 18 more tissue bank inspections.
• Consult with the Center for Veterinary Medicine on developing compliance guidance and revising the electronic review criteria, (i.e. may proceed criteria) based on current risk assessments and risk-based decision making of imported products.
• Conduct 30 additional inspections for illegal drug residue and chemical contaminants in animal feed and increase sampling.
• Assure current information is available to import examiners to make well-founded regulatory decisions.
• Improve imported medical device compliance by increasing surveillance and product testing of these products.
• Increase domestic medical device surveillance by conducting 150 additional inspections of manufacturers.
• Improve the confidence that FDA has in the safety of foreign drugs, biological and device products by working towards implementation of the European Mutual Recognition Agreement and by intensifying drug inspections in developing countries.

User Fees

• Improve the effectiveness of cargo control activities at Ports, and the monitoring of products that have been refused entry pending exportation or destruction, by working with the U.S. Customs Service to increase coordination of import activities.
• Increase import surveillance by expanding import entry review resources to keep pace with the increase in line entries.
• Improve import surveillance activities by increasing the frequency of on-screen entry review and updating on a risk basis the criterion that determines which import line entries are selected for on screen review.
• Modernize the Operational and Administrative System for Import Support (OASIS) import data processing system to allow import reviewers to have rapid and direct access to information necessary for entry decisions.
• Increase data audits, import filer training, and liaison activities to ensure the integrity of import data submitted by import filers.

Patient Safety/AERS + $1,000,000 and 6 FTE

• Increase patient safety by holding more public meetings to educate consumers and other stakeholders about the prevention and reporting of medical errors.
• Reduce medical errors by conducting more investigations of reported errors to collect information that program managers need to assess the error and develop error reduction strategies with manufacturers and the medical community.
• Accelerate the upgrade of field investigational data systems to complement Agency error tracking systems to provide better information on the incidence of medical errors.

Human Subject Protection + $6,400,000 and 32 FTE

• Increase direct FDA oversight of bioresearch through an increase of 205 BIMO inspections in the Human Drugs (80), Biologics (50), and Device (75) programs.
• Improve the quality, consistency, and effectiveness of bioresearch monitoring (BIMO) inspections by developing an investigators’ certification program to provide training and practical experience and assure that investigators keep pace with emerging issues in clinical research.
• Improve compliance with the bioresearch regulations through a timely Clinical Investigator Disqualification Process and improve the consistency of these disciplinary actions among drugs, biologics, and device programs.
• Improve the safety and quality of foreign bioresearch activities by developing new relationships with foreign governments and participating in international regulatory standards organizations.

Food Safety + $9,300,000 and 44 FTE  (Budget Authority  + $5,400,000 and 27 FTE; User Fees  + $3,900,000 and 17 FTE)

Budget Authority

• Increase the number of State contract inspections by 1,000 (to a total of 4,700) by expanding the funding and coordination of State contract inspections.
• Improve food safety activities by the States by expanding State audit inspections, enforcement, and data reporting for State inspectional and compliance activities.
• Increase the utilization of State inspectional data and findings by having more States enter inspection data directly into FDA field data systems.
• Improve the safety of the domestic food supply by conducting 400 more domestic sample analyses for food borne pathogens and contaminants.

User Fees
Food Safety-Export Certification

• Facilitate international trade by preparing export certificates on a timely basis and in the languages required by current international agreements.
• Provide reimbursement of operating costs to allow existing food safety resources to be more effectively utilized for inspections and sample analyses.

Current Law User Fees + $1,380,000
Prescription Drug User Fee Act (PDUFA)  + $1,375,000

The Food and Drug Administration Modernization Act of 1997 reauthorized the collection of user fees to enhance the review process of new human drugs and biological products through FY 2002 and established fees for applications, establishments, and approved products.  In FY 2002, based on the information currently available and the statutory PDUFA formulas, an increase of $1,375,000 is included for the field activities.

Mammography Quality Standards Act + $5,000

The Mammography Quality Standards Act (MQSA) of 1992 was reauthorized in 1998 for an additional five years (P.L. 105-298).  FDA requests an increase of $5,000 in MQSA authorized inspection user fees to cover inflationary costs.  The fees collected will pay for overhead costs related to inspections.

JUSTIFICATION OF BASE

Activities Related to Increases for FY 2002

Payroll

• ORA is primarily responsible for conducting inspections of regulated industry, and collecting and analyzing samples.  Other activities that often arise are review and management of enforcement actions, consumer complaints, trace back efforts to determine the cause of food borne illness outbreaks, and review of import entries for admissibility decisions.   These functions are inherently governmental and highly personnel intensive.

Bovine Spongiform Encephalopathy (BSE)

• Conduct inspections of licensed and unlicensed feed mills for compliance with BSE regulations.
• Coordinate with State agencies to enforce the BSE regulations.

Imports and Inspections

• Provide criminal investigation of reported product tampering; counterfeit products and other fraudulent criminal activities involving regulated products.
• Provide emergency operation, investigation and response for incidents involving regulated products.
• Develop laboratory analytical methods to permit the analyses of products for chemical and microbiological hazards.
• Inspect about 14,000 domestic and 900 foreign establishments.
• Fund about 13,600 State contract inspections.
• Review 6,300,000 import line entries for admissibility into domestic commerce.

Patient Safety/AERS

• Provide training for field staff to improve the information gathered through investigation of consumer complaints.
• Provide health education for U.S. consumers about FDA-regulated products, which may impact their health adversely.

Human Subject Protection

• Conduct Bioresearch Monitoring inspections and data audits in the human and animal drug, biologic, and medical device areas to monitor the methods and reporting of FDA regulated research.
• Inspect clinical investigators to protect the rights and welfare of human subjects involved in FDA regulated research, and to assure the quality and integrity of data submitted to the Agency in support of new product approvals.

Food Safety

• Conduct inspections of all high-risk domestic food establishments currently identified at 6,250.   Laboratory capabilities are being enhanced for the analytical support associated with the level of inspectional activity.  High-risk establishments include processors of infant formula; processors of ready to eat foods, or produce; seafood product processors; low-acid canned food processing plants and juice processors.
• Identify the food source and contaminant of food borne illness outbreaks ranging from chemical, microbiological, and physical hazards.
• Continue State contract audit inspections to ensure consistent application of regulations nationwide by FDA and the States.
• Replace outdated field laboratory equipment to improve the accuracy and timeliness of food product analyses to determine compliance with safety requirements.

Activities Related to Other Priority Areas

Internet Drug Sales

• Continue the monitoring of potentially fraudulent Internet sites to identify targets for investigation and sampling of products.
• Conduct undercover online purchases of prescription drugs from Internet sites suspected of engaging in illicit drug sales, distribution, and/or marketing.
• Reduce the health risks to individuals ordering pharmaceuticals from foreign sources over the Internet by providing oversight of mail and courier packages entering from foreign sources and destined for individuals, e.g., personal importations. These personal importations are largely excluded from FDA’s electronic import data system.

Premarket Activities

• Improve the quality and timeliness of product reviews through monitoring pre-approval inspections and by expanding inspectional expertise in emerging technologies and expanding quality assurance to monitor the inspection process.
• Recruit, hire and train new investigators and provide training, information technology and contract support to improve the scientific expertise of field investigators. This training enables the investigators to conduct the pre-market inspections that are essential to meet pre-market review time frames.

Countering Bioterrorism

• Participate in the planning for and coordination of exercises simulating responses to bioterrorist attacks.
• Develop a notification system for bioterrorism incidents  (including hoaxes) with the Federal Bureau of Investigations (FBI) who will notify FDA through our 24-hour emergency number regarding any threat that may involve an FDA regulated product.
• Inspect of drug and vaccine manufacturers whose products may be stockpiled as part of the Government’s bioterrorist efforts.

International Activities

• Plans for FDA’s international inspection program continues to be one of the Agency’s top priorities as more FDA regulated products originate from foreign sources.  The Agency’s international inspection program is paramount in attaining confidence that all imported FDA regulated products meet the same standards as domestic goods.   While FDA is working to foster effective international inspection cooperation agreements, the primary tool for this assurance is for FDA to conduct international inspections.  

Selected FY 2000 Accomplishments

Science

• Implementation of Pulsed Field Gel Electrophoresis (PFGE). DNA finger printing by PFGE is one of the most important tools to combat food borne outbreaks.  ORA established PFGE capability in five field laboratories.   This method can provide timely identification of the source of contamination.  This technique has been successfully used in several outbreak situations involving Salmonella and Listeria monocytogenes. 
• Development of Antibiotics Sensitivity Screening of Salmonella.   The emergence of antibiotics resistance has become a major public health concern.  Of particular interest is the emergence of Salmonella with resistant genes to multiple antibiotics.  FDA needs data on the extent of antibiotic-resistant Salmonella in our food supply.  ORA has established a program of screening Salmonella isolates from foods in our Denver laboratory.   In FY 2000, about 250 Salmonella isolates were screened and several multiple-antibiotic resistant strains were found.
• Imported Produce Analyzed for Pathogens. ORA analyzed 1,000 fresh imported produce samples for microbiological pathogens.  This first systematic look at this dietary significant group of foods for pathogens found approximately 5 percent of the samples contained pathogens.  Pathogens detected were Shigella and Salmonella spp.   Commodities found positive included: cantaloupe, celery, cilantro, green onions, lettuce and parsley.

Investigations

• ORA conducts inspections to evaluate regulated establishment operations against appropriate Agency requirements.  Inspections evaluate manufacturing processes; record-keeping systems; warehousing practices; packaging or labeling processes; quality control laboratories; and, integrated livestock feeding practices.  During FY 2000, ORA conducted 15,146 inspections, including 880 foreign and 14,266 domestic inspections.
• Domestic inspections funded by FDA appropriations may be conducted by either FDA staff or by States under contract to FDA.  When States conduct inspections under contract, FDA is required to audit these inspections.   There were 13,900 State contract inspections.  Of these, approximately 8,900 were inspections of mammography facilities; about 1,000 were of feed mills; another 350 were tissue residue; and, the rest, about 3,700, were food inspections.

Partnership and Support for States

• FDA Funding of State/Local Task Forces.  FDA funded 19 State Food Safety Task Forces with Small Conference Grants totaling $96,500 and 13 grants totaling $530,000 for Innovative Food Safety Projects to State and local regulatory agencies that were intended to complement, develop and/or improve food safety programs.
• State Contracts. FDA awarded 39 state food contracts for over 5,100 food inspections for a total of $2,617,000; 19 state medicated feed contracts for 453 GMP/BSE inspections and 96 BSE-only inspections for a total of $330,000; 15 state tissue residue contracts for 548 inspections for a total of $260,000; and negotiated and awarded 47 Mammography Quality Standards Act (MQSA) contracts.
• Partnerships.   At the close of FY 2000, there were over 177 Partnership Agreements between FDA and various State/local regulatory agencies, associations, industry, and academia.  This represents an increase of approximately 12.7 percent over FY 1999.

Enforcement Activities

Protection of Participants in Gene Therapy Trials

• FDA and NIH announced two new programs to further strengthen the safeguards for individuals enrolled in clinical studies for gene therapy.  These two new programs -- the Gene Therapy Clinical Trial Monitoring Plan and the Gene Transfer Safety Symposia -- are part of ongoing efforts to ensure the safety of patients enrolled in gene therapy clinical trials.
• University of Pennsylvania.  From November 1999 to January 2000, FDA conducted an inspection of the Institute for Human Gene Therapy located at the University of Pennsylvania. Subsequently, FDA placed all trials sponsored by Dr. James Wilson, Director of the Institute, on clinical hold. Following issuance of a Warning Letter, the University determined that it would no longer conduct experiments on humans.
• St. Elizabeth’s Medical Center.  In February 2000, FDA put the gene therapy research being conducted at St. Elizabeth’s Medical Center of Boston on clinical hold.   Following an inspection in March 2000, a Warning Letter was issued concerning violations of regulations governing the proper conduct of clinical studies and the protection of human subjects.

Consent Decrees

• Abbott Laboratories.  In November 1999, Abbott Laboratories signed a Consent Decree of Permanent Injunction related to manufacturing problems concerning many of its in-vitro diagnostic tests.   As an equitable remedy of disgorgement, the firm also agreed to pay $100,000,000 to the U.S. Treasury.   The dollar amount sets a precedent as the largest amount of money ever paid by an FDA-regulated company for a civil violation of the Federal, Food, Drug and Cosmetic Act.
• Wyeth-Ayerst Laboratories.  In October 2000, Wyeth-Ayerst Laboratories Division of American Home Products Corporation and Wyeth-Ayerst Pharmaceuticals, Inc., signed a Consent Decree of Permanent Injunction based on a failure to comply with FDA's GMP regulations.   As an equitable remedy of disgorgement, Wyeth also agreed to pay $30,000,000 to the U.S. Treasury.

Recalls

• Clinipad Antiseptic Sterile Products.  An FDA inspection of Clinipad Corp., Charlotte, NC, in January and February 2000, resulted in the recall of over 925,000,000 sterile products and 900,000,000 non-sterile products because of CGMP deviations.   Recall of these products involved three program areas – Drugs, Devices, and Biologics.
• Rich’s MSM Eye & Ear Drops.  In response to a consumer complaint, FDA laboratory analysis of a sample of Rich's MSM Eye & Ear Drops revealed contamination with yeast and a bacteria that can cause severe, and potentially sight-threatening, eye injuries.  This resulted in a Class I recall in August 2000.
• Dialysis Catheter Anticoagulant – TriCitrasol.  In April 2000, a Class I recall resulted when an FDA investigation that was initiated in response to an adverse medical report disclosed that triCitrasol, an unapproved dialysis catheter anticoagulant, may cause death when infused into patients.  A patient death was, in fact, associated with use of the product.
• Dietary Supplements Containing the Prescription Diabetic Drug Glycuride.   During February and March 2000, several recalls of herbal products were initiated due to the presence of undeclared prescription diabetic drugs, glycuride and phenformin.   Both drugs are used to lower blood sugar.  Recalls of such products were initiated by Sino American Health Products, Inc.; Chinese Angel Health Products, Inc.; and, Diabetic Capital (US) LLC.

Internet Drug Sales

• FDA continues to take regulatory and enforcement actions against violative Internet drug firms.   There are several reviews for regulatory action underway, and numerous active criminal investigations.   ORA continues to issue cyber letters to violative foreign pharmacy sites and is extending the use of cyber letters to domestic sites.  Sites selling recreational drugs, as well as those identified in a recent rash of cases involving the sale of bulk active drug ingredients to persons who distributed it illegally in capsules are receiving increased attention.   The Internet Prescription Drug Sales Act of 2000 was transmitted to Congress in support of this activity.
• Christian Brothers Contracting Corporation Case. In April 2000, Judge John Gleeson of the Eastern District of New York, signed an order granting the Government preliminary injunctive relief against Christian Bros. Contracting Corp., and its President, Jason Vale, who had promoted laetrile (amygdalin), an illegal cancer treatment, via multiple web sites.

Imports

• Global Harmonization.  In the area of medical devices, ORA has been involved in many activities that fall under the concerns of global harmonization.  ORA has representation on the Global Harmonization Task Force, which has membership from Canada, the EU, Japan, and Australia as well as industry members.   The group has been developing guidance on quality auditing, quality auditor qualifications, and quality audit reports.
• BSE Issues.  FDA provided technical expertise and assistance to USDA in identifying entry criteria for import examination.  FDA provided early information to its field offices in the identification of products susceptible to BSE contamination, and instructions regarding forwarding of this information to local USDA/APHIS offices.
• On December 7, 2000, USDA/APHIS enacted an immediate prohibition on the importation of all meat and bone meal (MBM), bone/meat/blood meals, tankage, offal or any product containing such, which originates directly from Europe or was rendered/processed in European plants processing animal materials, regardless of the species of origin, including poultry and fish meal.  This action was deemed necessary because of the possibility of cross contamination with the BSE agent.  FDA issued an import bulletin (71-B02) on December 20, 2000, to disseminate this information to field import offices and to provide guidance to districts when they encounter any of these products.  An import alert is currently being developed and should issue in 2001 to further enhance enforcement strategy with regards to these products.  ORA’s Division of Import Operations and Policy is working very closely with CVM on this issue as well as with counterparts in USDA/APHIS.
• API/Bulk Drugs. FDA has provided joint FDA/Customs enforcement instruction to approximately 200 field personnel.   FDA has engaged a private contractor (Battelle) to examine FDA's import strategy/procedures and to develop new Information Technology products to assist in import surveillance.

Training

• Investigator Certification. Certification is designed to provide investigators with training to facilitate standardization of scientific investigations (and inspections) across the Agency.   The Device Certification Program has expanded into the Seafood Products and Blood Bank and Plasma Center areas.  There are ten seafood investigators certified at the Level II; twelve certified at Level II in the Blood Banks and Plasma Center Program.  Currently 110 investigators have been certified in the Medical Device Program.
• Partnership and Support for States.  ORA trained 1,879 State, local health department officials to further compliance with FDA policies and procedures for investigators.  This training is critical to the mission of the Agency to train State employees to conduct investigations and meets ORA’s commitment to work proactively with state agencies to protect the public health.  
• FACTS.  The Field Accomplishments and Compliance Tracking System (FACTS) was developed to centralize the data gathered by ORA into one nation-wide system.  Four courses were conducted during the past year with 124 participants in attendance.

Emergency Operations

• FDA tracked and investigated 98 pathogen-related incidents during FY 2000.  Examples of food borne pathogens tracked which spread across several states include a “salmonella meunchen outbreak” in mangoes that broke out in 13 states; a norwalk-like virus in potato salad that occurred in 11 states; and, a salmonella anatum outbreak which occurred in frozen carrots and peas that occurred in 8 states and Canada.
• Non-pathogen related incidents were also investigated by FDA.  Approximately 97 non-pathogen related incidents were recorded.   Examples of non-pathogen-related incidents are grouped in several areas: adverse reactions; injuries; chemical contaminants;   tampering; infections; recalls; foreign objects; natural disasters; counterfeit labeling; drug residues; and, death.  For instance, an example of an adverse reaction incident involves a reaction to a vaccine that resulted in the death of an infant; or, counterfeit labeling in infant formula in the state of California.  Other types of non-pathogen related incidents happen in natural disasters such as a tornadoes in Texas and Minnesota; Hurricane Irene; a fire in Los Alamos, New Mexico; and flooding in New Jersey.

PROGRAM ACTIVITY DATA CHARTS

Field Foods
Field Cosmetics
Field Human Drugs
Field Biologics
Field Animal Drugs and Feeds
Field Medical Devices and Radiological Health

The on-site examination of a domestic product (or a foreign product in domestic channels of trade) that is sufficient in itself to determine whether the product is in compliance with the Acts enforced by FDA.  Examples of food exams include visual, organoleptic (sensory examination most often associated with the evaluation of decomposition of seafood), quick color (used for rapid test methods which do not require instrumentation and rely on the quick development of color as the test result) and rapid abrasion tests (used for the determination of toxic metals due to the fact that abrasion exposes colored surfaces likely to contain metals).

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