Inspections, Compliance, Enforcement, and Criminal Investigations
1999 Warning Letters
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Warning Letters for 1999
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* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.
Read more about warning and close-out letters
Posted on May 26, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 30, 1999 | Universal Packaging Systems Inc. | Los Angeles District Office | CGMP/Finished Pharmaceuticals | N/A * |
December 30, 1999 | Raphah Inc. | New Jersey District Office | Food Labeling | N/A * |
December 30, 1999 | Breger Vision | Center for Devices and Radiological Health | Contact Lenses/Lacks Premarket Approval/Misbranded | N/A * |
December 30, 1999 | Medical Developmental Research Inc. | Center for Devices and Radiological Health | Sponsor/Monitor/Contract Research Organization | N/A * |
December 29, 1999 | N. V. N. Inc. | New Jersey District Office | Seafood Processing Regulations/HACCP | N/A * |
December 27, 1999 | Paynesville Area Health Care System | Minneapolis District Office | Mammography Standards | N/A * |
December 27, 1999 | TUCO Innovations Inc. | Center for Devices and Radiological Health | Laser Therapy Devices | N/A * |
December 27, 1999 | ConAgra Inc. | Kansas City District Office | Medicated Feeds/CGMP | N/A * |
December 23, 1999 | Fantis Foods Inc. | New Jersey District Office | Seafood Processing Regulations/HACCP | N/A * |
December 23, 1999 | Alliance Medical Corporation | Florida District Office | Quality System Regulation/Medical Devices Processing | N/A * |
December 23, 1999 | Genetics Institute | Center for Biologics Evaluation and Research | CGMP Deviations | N/A * |
December 23, 1999 | Diasorin s.r.l. | Center for Biologics Evaluation and Research | Quality System Regulation | N/A * |
December 23, 1999 | Tower Rubber Industries Sdn Bhd | Center for Devices and Radiological Health | Quality System Regulation/Patient Examination Gloves | N/A * |
December 23, 1999 | Miller's Homecare Services | New Jersey District Office | Oxygen Repackaging Facility | N/A * |
December 22, 1999 | Amelia Springs Water Inc. | Baltimore District Office | Bottle Water Operation | N/A * |
December 22, 1999 | Entrees Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
December 22, 1999 | Associates of Cape Cod Inc. | Center for Biologics Evaluation and Research | Quality System Regulation/Biologics Listing etc. | N/A * |
December 22, 1999 | Coulston Foundation | Center for Drug Evaluation and Research | GLP (Good Laboratory Practices) | N/A * |
December 22, 1999 | Salmolux Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
December 22, 1999 | D and M Dairy | San Francisco District Office | Food/Cattle | N/A * |
December 21, 1999 | Mountain Products Inc. | New York District Office | Seafood Processing Regulations/HACCP | N/A * |
December 21, 1999 | Fabrica de Flanes Acevedo | San Juan District Office | Food Labeling | N/A * |
December 21, 1999 | Progressive Dairy #1 | San Francisco District Office | Food/Cattle | N/A * |
December 21, 1999 | Northwest Airlines | New York District Office | PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations | N/A * |
December 21, 1999 | Emapacadora La Montana, Inc. | San Juan District Office | GMP for Deviations/Adulterated/Misbran ded | N/A * |
December 20, 1999 | Shared Medical Technology | Minneapolis District Office | Mammography Standards | N/A * |
December 20, 1999 | H. B. Gordon manufacturing Co. Inc. | Los Angeles District Office | Finished Pharmaceuticals | N/A * |
December 20, 1999 | Staten Island University Hospital | New York District Office | Blood & Blood Components | N/A * |
December 20, 1999 | Capt. Vince Inc. | New England District Office | Seafood Processing Regulations/HACCP | N/A * |
December 20, 1999 | Westfield Memorial Hospital | Buffalo District Office | Mammography Standards | N/A * |
December 20, 1999 | Danmar Product Inc. | Center for Devices and Radiological Health | Medical Devices / Premarket Approval Application [PMA] | N/A * |
December 20, 1999 | Bassett Healthcare | New York District Office | Mammography Standards | N/A * |
December 20, 1999 | Thatcher Company | Denver District Office | Active Pharmaceutical Ingredient | N/A * |
December 20, 1999 | Cooksey James R. | Cincinnati District Office | Food/Cattle | N/A * |
December 20, 1999 | Disetronic Medical Systems Inc. | Minneapolis District Office | Quality System Regulation/Infusion Pumps | N/A * |
December 17, 1999 | Hoffmann-LaRoche Inc. | New Jersey District Office | CGMP/Finished Pharmaceuticals | N/A * |
December 17, 1999 | Health Care Solutions Inc. | Detroit District Office | Medical Oxygen / CGMP | N/A * |
December 17, 1999 | Ortho Clinical Diagnostics Americas | Los Angeles District Office | Laser Therapy Device/Lacks Premarket Approval/Misbranding/Mislabeling | N/A * |
December 17, 1999 | Baton Rouge Clinic AMC | New Orleans District Office | Mammography Standards | N/A * |
December 17, 1999 | Thames Pharmacal Co. Inc. | New York District Office | Finished Pharmaceuticals | N/A * |
December 17, 1999 | Rynsburger Dairy | San Francisco District Office | Food/Cattle | N/A * |
December 16, 1999 | Amanda Animal Hospital | Cincinnati District Office | Food/Cattle | N/A * |
December 16, 1999 | Gourmet Award Foods SE | Florida District Office | Food/Hearts of Palm | N/A * |
December 15, 1999 | Basha Diagnostics P.C. | Detroit District Office | Mammography Standards | N/A * |
December 15, 1999 | International Sterilization Laboratory Corporation | Florida District Office | Quality System Regulation/Medical Devices Contract Sterilization | N/A * |
December 14, 1999 | Radiology & Imagaing Inc. | New England District Office | Mammography Standards | N/A * |
December 14, 1999 | St. Luke's Hospital | Minneapolis District Office | Mammography Standards | N/A * |
December 14, 1999 | Bladen County Hospital | Atlanta District Office | Mammography Standards | N/A * |
December 14, 1999 | Grand Strand Regional Medical Center | Atlanta District Office | Mammography Standards | N/A * |
December 14, 1999 | American Eagle Airlines Inc. | Minneapolis District Office | Control of Communicable Disease and Interstate Conveyance Sanitation | N/A * |
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