Contents

6.4 - FIELD EXAMINATION

6.4.1 - GENERAL

A field examination is simply an on-the-spot examination or field test performed on a product to support a specific decision. It may be conducted on products discharged from vessels on to the wharves (piers), pier sheds, and other locations; products in trucks, trains, freezers, and containers, etc., at border entry points; or on products set aside for FDA examination. Some compliance program guidance manuals do not address field examinations. Nevertheless, field examinations are appropriate for certain problems and/or commodities and should be conducted.

A field examination involves actual physical examination of the product for such things as storage or intransit damage, inadequate refrigeration, rodent or insect activity, lead in dinnerware (Quick Color Test - QCT), odor and label compliance

A field examination does not have the same level of confidence as a laboratory examination. Consequently, more rigorous standards of acceptance are applied than those used for formal regulatory levels. For example, if the formal action guideline for whole insects is 10 per 100 gm in product X, you may sample product X when your field examination shows only one or two insects per 100 gm. The decision to sample is, to some degree, left to your discretion. In most instances, it should be based on findings significantly lower than specified by the formal guideline.

A field examination begins when the physical examination is started. Do not include, as reported Field Examination time, the time to locate the lot or travel time. Time spent in locating the lot is reported as import investigation.

See IOM 5.1.4.3 for suggestions on what to do when conducting a field examination and the firm responsible for the products invites individuals who are not directly employed by the firm to observe the examination.

6.4.2 - FIELD EXAMINATION SCHEDULE

A Field Examination should include a physical examination of a minimum of five containers (cases, cans, bags, etc.) of a product, or as directed by Compliance Program Guidance Manuals, specific product examination schedules (e.g., LACF), or other guidance.

When you conduct any field examination of a product's label or labeling, in addition to the specific items discussed in the following sections, be alert for any overlabeling where a product name or identify may have been changed; products without mandatory English labeling; changes in expiration date or lot numbers or similar questionable practices. If you encounter any of these items, collect an example and discuss the appropriate action with your supervisor.

6.4.3 - FIELD EXAMINATIONS - FOODS

See IOM 5.4.1.4.2 for guidance on performing reconciliation examinations during import field examinations.

6.4.3.1 - Food Sanitation

Microbiological - field examinations can not be used for suspected microbiological contamination.

Filth and Foreign Objects - field examine only those product/container combinations in which you can physically view and examine the product, e.g., products which can be probed, products in see-through containers, etc. See 5.1.5, et al for some specific guidance on performing field examinations.

Low acid and other Canned Foods - See IOM SAMPLE SCHEDULE CHART 2.

Decomposition in Non-sealed Foods - This can include organoleptic examination for fish, seafood, frozen eggs, etc.

6.4.3.2 - Pesticides, Industrial Chemicals, Aflatoxins, & Toxic Elements

Field examinations can not be performed for most of these materials, except for metals in dinnerware and the side -seam solders of cans.

NOTE: Districts should use commercial versions of the Quick Color Test (QCT) and the Rapid Abrasion Test for lead, e.g. Lead Check Swabs, for the field examination of dinnerware and food cans to determine if follow-up sampling is required. The testing scheme for dinnerware can be found in CPGM 7304.019B.  Specific information regarding the techniques of testing dinnerware and can side-seam solder can be found in Lab Information Bulletin (LIB) 4127 and LIB 4041, respectively on the DFS intranet site.

6.4.3.3 - Food and Color Additives

The only valid field examination which can be performed for these materials is a visual examination through the container and a label review for the mandatory labeling requirements, i.e., is a color additive declared for a product without natural coloring; determining if an additive declaration includes its function, for example, "Sodium Benzoate as a preservative".

NOTE: Label examination of products to determine whether there is a declaration of certain food and/or color additives must be reported as an import investigation.

6.4.3.4 - Nutrition and Nutrition Labeling

6.4.3.5 - Food Economics (On consumer size containers only)

Label Examination - Review labels for all aspects of the labeling requirements.

Net weight - See IOM 4.3.8.1

Food Standards - The only valid field examination which can be performed for Food Standards is a label examination for the mandatory labeling requirements of a particular Food Standard.

NOTE: Label examinations of products to determine if the labeling meets the mandatory labeling requirements for a particular Food Standard must be reported as an Import Investigation.

6.4.3.6 - Cosmetics

Valid cosmetic field examinations include a reconciliation examination for security purposes and/or a label examination for the mandatory labeling requirements. The most important labeling considerations are:

1. Ingredient Labeling (21 CFR 701.3),
2. Prohibited ingredients (21 CFR 700.11 through 700.27 and 250.250),
3. Non-permitted color additives  (see Color Additives Status Lists at http://www.cfsan.fda.gov/~dms/opa-appa.html#col),
4. Warning Statements (21 CFR 740.11, 740.12, 740.17, and 740.19 ).
5. Cautionary/Other Required Statements (FD&C Act sec. 601(a), 21 CFR 73.2396, 73.2110, and 73.2190)
6. Tamper Resistant Packaging Requirements (21 CFR 700.25)

NOTE: Label examinations of products to determine whether their labeling declares certain ingredients must be reported as an Import Investigation.

6.4.4 - FIELD EXAMINATION - DRUGS

When you conduct field examinations of drugs (bulk drugs and finished dosage forms) ensure you check:

1. Labeling compliance (e.g., Reye Syndrome warning)
2. Probable contamination
3. Tamper Resistant Packaging Requirements

6.4.4.1 - Labeling

Bulk drugs and finished dosage forms should be evaluated for compliance with the Drug Listing Act, 21 CFR 207.40. Refer to the Drug Listing Compliance Program Guidance Manual.

6.4.4.2 - Contamination

Drugs should be examined for container integrity, e.g.: cracked vials, ampoules, bottles, etc.

6.4.4.3 - Samples

A decision to collect samples for Drug Listing Act compliance evaluation should be made in accordance with the drug listing CPGM. The nature of samples to be taken from lots where the drug substance or finished product has been subjected to actual or suspected contamination, should be decided on a case-by-case basis.

6.4.4.4 - Special Instructions

Field examinations may be made of drug lots to obtain information in determining the new drug status of a given shipment. Districts should contact the Division of New Drugs and Labeling Compliance, Import/Export International Drug Team, (HFD-319) for guidance.

6.4.5 - FIELD EXAMINATIONS - DEVICES

Medical device field exams include electrode lead wires, patient cables, labeling, and physical damage. Lead wires and patient cable exams should conform to applicable standards set forth in 21CFR Part 898.

6.4.6 - FIELD EXAMINATIONS - BIOLOGICS

Review RPM Chapter 9-3 "Importation of Biological Products" and the Import Alert regarding biologics prior to conducting any field examinations of biological products.

In general, products controlled by Center for Biologics Evaluation and Research (CBER) do not require field examination, because they are licensed under Section 351 of the PHS Act. In addition, lot release procedures pursuant to 21 CFR 610.2 apply to many products, such as vaccines.

Products imported under IND Applications are also monitored, but due to the small volumes involved, no specific guidance is necessary.

Shipments of biologics which are not licensed, or are not directly related to an active IND should be examined for:

1. Labeling
2. Consignee
3. Manufacturer
4. Intended use

Contact CBER/OC/Division of Case Management (HFM-610) for guidance.

6.4.7 - FIELD EXAMINATIONS - VETERINARY PRODUCTS

Contact the CVM Division of Compliance (HFV-230), the Enforcement and Regulatory Policy Team, with general questions on the importation of veterinary products. You should be aware of various Import Alerts, Compliance Policy Guides or Guidance Documents as they affect individual import situations. See the CVM website for additional information or notifications on current import situations

6.4.7.1 - Drugs

Field examinations of veterinary drugs are visual examinations to determine potential misbranding or adulteration. This may include examination for:

1. Container Integrity
2. Labeling Compliance
3. Product adulteration

Dosage form drugs must be examined to determine if they are new animal drugs. If the products are new animal drugs, you need to determine if an approved NADA/ANADA exists or if there is a valid INAD exemption in place. You should consult with CVM's Division of Compliance (HFV-230) regarding the status of imported veterinary products (301-827-1168).

Bulk New Animal Drug substances and Active Pharmaceutical Ingredients (APIs) may be legally imported only if destined to the holder of an approved NADA or INAD exemption. You will need to consult with the Center for the status of particular drugs.

Entries of prescription animal drugs for use by the consumers (laymen) must be examined for labeling content, consignee (name and address) and to determine if a valid prescription/order exists from an appropriately licensed veterinarian. The Center (301-827-1168) should have records of any exemptions or permission granted for personal imports.

6.4.7.2 - Devices

Devices intended for animal do not require premarket approval. However, they are still subject to examinations for misbranding violations. Animal devices must bear adequate directions for use and label claims must not be false or misleading. You should consult with CVM for guidance (301-827-1168).

6.4.7.3 - Animal Feed

Animal feeds and feed components, including pet foods should be examined for conformance with all applicable and appropriate food labeling requirements, drug claims, food additive violations and use of banned or objectionable ingredients as well as filth and foreign objects. You should consult with CVM on individual issues and to determine specific requirements (301-827-1168).

6.4.7.4 - Animal Grooming Aids

Cosmetics for animals are referred to as "animal grooming aids". While the Center does not actively pursue enforcement actions with animal grooming aids, the products are expected to be safe, effective and properly labeled. The labels and labeling of any incoming animal grooming aids are subject to examination and review for potential instances of misbranding. Consult with the Center for appropriate guidance. The Division of Compliance (301-827-1168) can answer regulatory and enforcement questions. The Division of Surveillance (301-827-0158) tracks reporting of complaints and adverse reactions, including those for animal grooming aides.

6.4.7.5 - Biologicals

CVM does regulate animal biologic products. They are considered as drugs. However, the Center does not regulate animal vaccines. The vaccines are regulated by USDA/APHIS.

6.4.8 - FIELD EXAMINATIONS RADIOLOGICAL HEALTH

Field Examinations for imported electronic products consist of reviewing the Entry Documents and FDA-2877, Declaration for Products Subject to Radiation Control Standards, to determine if they are properly completed and accurate. This applies to each shipment of electronic products for which performance standards exist. Performance standards, covering ionizing, optical, microwave and acoustic radiation-emitting products, are specified in 21 CFR 1020 through 1050.

For electronic products, physical samples may only be collected on specific assignment. DTR/DER recommendations are to be submitted when the Field Examination indicates the product may not be in compliance and detention is recommended.

Import coverage for radiation emitting products is provided for in a CDRH Compliance Program Guidance Manual. Do not collect physical samples except on specific assignment, or with concurrence of CDRH.

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