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 * |
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