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Inspections, Compliance, Enforcement, and Criminal Investigations
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1999 Warning Letters
Warning Letters for 1999
| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| December 30, 1999 | Universal Packaging Systems Inc. | Los Angeles District Office | CGMP/Finished Pharmaceuticals |
| December 30, 1999 | Breger Vision | Center for Devices and Radiological Health | Contact Lenses/Lacks Premarket Approval/Misbranded |
| December 30, 1999 | Raphah Inc. | New Jersey District Office | Food Labeling |
| December 30, 1999 | Medical Developmental Research Inc. | Center for Devices and Radiological Health | Sponsor/Monitor/Contract Research Organization |
| December 29, 1999 | N. V. N. Inc. | New Jersey District Office | Seafood Processing Regulations/HACCP |
| December 27, 1999 | Paynesville Area Health Care System | Minneapolis District Office | Mammography Standards |
| December 27, 1999 | TUCO Innovations Inc. | Center for Devices and Radiological Health | Laser Therapy Devices |
| December 27, 1999 | ConAgra Inc. | Kansas City District Office | Medicated Feeds/CGMP |
| December 23, 1999 | Genetics Institute | Center for Biologics Evaluation and Research | CGMP Deviations |
| December 23, 1999 | Tower Rubber Industries Sdn Bhd | Center for Devices and Radiological Health | Quality System Regulation/Patient Examination Gloves |
| December 23, 1999 | Miller's Homecare Services | New Jersey District Office | Oxygen Repackaging Facility |
| December 23, 1999 | Fantis Foods Inc. | New Jersey District Office | Seafood Processing Regulations/HACCP |
| December 23, 1999 | Alliance Medical Corporation | Florida District Office | Quality System Regulation/Medical Devices Processing |
| December 23, 1999 | Diasorin s.r.l. | Center for Biologics Evaluation and Research | Quality System Regulation |
| December 22, 1999 | Coulston Foundation | Center for Drug Evaluation and Research | GLP (Good Laboratory Practices) |
| December 22, 1999 | Associates of Cape Cod Inc. | Center for Biologics Evaluation and Research | Quality System Regulation/Biologics Listing etc. |
| December 22, 1999 | Salmolux Inc. | Seattle District Office | Seafood Processing Regulations/HACCP |
| December 22, 1999 | Entrees Inc. | Seattle District Office | Seafood Processing Regulations/HACCP |
| December 22, 1999 | D and M Dairy | San Francisco District Office | Food/Cattle |
| December 22, 1999 | Amelia Springs Water Inc. | Baltimore District Office | Bottle Water Operation |
| December 21, 1999 | Progressive Dairy #1 | San Francisco District Office | Food/Cattle |
| December 21, 1999 | Fabrica de Flanes Acevedo | San Juan District Office | Food Labeling |
| December 21, 1999 | Northwest Airlines | New York District Office | PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations |
| December 21, 1999 | Mountain Products Inc. | New York District Office | Seafood Processing Regulations/HACCP |
| December 20, 1999 | Danmar Product Inc. | Center for Devices and Radiological Health | Medical Devices / Premarket Approval Application [PMA] |
| December 20, 1999 | Disetronic Medical Systems Inc. | Minneapolis District Office | Quality System Regulation/Infusion Pumps |
| December 20, 1999 | Westfield Memorial Hospital | Buffalo District Office | Mammography Standards |
| December 20, 1999 | Cooksey James R. | Cincinnati District Office | Food/Cattle |
| December 20, 1999 | Shared Medical Technology | Minneapolis District Office | Mammography Standards |
| December 20, 1999 | Bassett Healthcare | New York District Office | Mammography Standards |
| December 20, 1999 | Capt. Vince Inc. | New England District Office | Seafood Processing Regulations/HACCP |
| December 20, 1999 | Staten Island University Hospital | New York District Office | Blood & Blood Components |
| December 20, 1999 | H. B. Gordon manufacturing Co. Inc. | Los Angeles District Office | Finished Pharmaceuticals |
| December 20, 1999 | Thatcher Company | Denver District Office | Active Pharmaceutical Ingredient |
| December 17, 1999 | Health Care Solutions Inc. | Detroit District Office | Medical Oxygen / CGMP |
| December 17, 1999 | Ortho Clinical Diagnostics Americas | Los Angeles District Office | Laser Therapy Device/Lacks Premarket Approval/Misbranding/Mislabeling |
| December 17, 1999 | Baton Rouge Clinic AMC | New Orleans District Office | Mammography Standards |
| December 17, 1999 | Rynsburger Dairy | San Francisco District Office | Food/Cattle |
| December 17, 1999 | Thames Pharmacal Co. Inc. | New York District Office | Finished Pharmaceuticals |
| December 17, 1999 | Hoffmann-LaRoche Inc. | New Jersey District Office | CGMP/Finished Pharmaceuticals |
| December 16, 1999 | Amanda Animal Hospital | Cincinnati District Office | Food/Cattle |
| December 16, 1999 | Gourmet Award Foods SE | Florida District Office | Food/Hearts of Palm |
| December 15, 1999 | International Sterilization Laboratory Corporation | Florida District Office | Quality System Regulation/Medical Devices Contract Sterilization |
| December 15, 1999 | Basha Diagnostics P.C. | Detroit District Office | Mammography Standards |
| December 14, 1999 | Bladen County Hospital | Atlanta District Office | Mammography Standards |
| December 14, 1999 | Addison Gilbert Hospital | New England District Office | Mammography Standards |
| December 14, 1999 | Evergrade Healthcare Products SDN. BHD | Center for Devices and Radiological Health | Quality System Regulation/Examination Gloves |
| December 14, 1999 | Radiology & Imagaing Inc. | New England District Office | Mammography Standards |
| December 14, 1999 | Metrolina Women's Breast Center | Atlanta District Office | Mammography Standards |
| December 14, 1999 | American Eagle Airlines Inc. | Minneapolis District Office | Control of Communicable Disease and Interstate Conveyance Sanitation |
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