Inspections, Compliance, Enforcement, and Criminal Investigations
1998 Warning Letters
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Warning Letters for 1998
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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 18, 1998 | Labtician Ophthalmics | Center for Devices and Radiological Health | Good Manufacturing Practices Violations | N/A * |
| December 18, 1998 | American Eagle | New York District Office | CFR Deviations | N/A * |
| December 18, 1998 | SeraCare Acquisitions Inc. | Seattle District Office | Blood Products | N/A * |
| December 18, 1998 | International Medical Inc. | Florida District Office | Quality System Regulations / Medical Devices | N/A * |
| December 18, 1998 | Scottcare Corporation Inc. | Cincinnati District Office | N/A * | |
| December 18, 1998 | Dentek-Lasersystems Produktions Ges.m.b.H. | Center for Devices and Radiological Health | Laser Product Performance Standard | N/A * |
| December 18, 1998 | Evergreen Mills Inc. | Dallas District Office | Medicated Feeds | N/A * |
| December 18, 1998 | Novartis AG | Center for Drug Evaluation and Research | Postmarketing Adverse Drug Experience | N/A * |
| December 17, 1998 | Johnson Donald E. M.D. | Center for Drug Evaluation and Research | Clinical Investigator | N/A * |
| December 17, 1998 | Duesch?r Hilltop Jerseys | Minneapolis District Office | Food/Cattle | N/A * |
| December 17, 1998 | Advanced Vision Research | New England District Office | Labeling/Eye Drops | N/A * |
| December 16, 1998 | Reliv International Inc. | Kansas City District Office | Drug Products/Labeling | N/A * |
| December 16, 1998 | Virjo Seafood Inc. | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
| December 16, 1998 | Sherwood Brands Inc. | New York District Office | Federal Food Drug and Cosmetic Act Violations | N/A * |
| December 15, 1998 | Catfish Wholesale Inc. | New Orleans District Office | Food/Sanitation | N/A * |
| December 14, 1998 | Boston Electtrodomestici S.r.l. | Center for Devices and Radiological Health | Laser Products / Noncompliance | N/A * |
| December 14, 1998 | Knoll Pharmaceutical Co. | New Jersey District Office | CGMP/Finished Pharmaceuticals | N/A * |
| December 11, 1998 | Diasonics Ultrasound Inc. | San Francisco District Office | Devices/Ultrasound Probes | N/A * |
| December 11, 1998 | Control System Internation Inc. | Kansas City District Office | Devices/Shotwave Diathermy Device | N/A * |
| December 11, 1998 | Schneider's Fish & Seafood Corp. | New York District Office | Seafood Processing Regulations/HACCP | N/A * |
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