Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is a 71.4% decrease from the number of companies cited in the previous quarter.
Of the 23 citations issued, the most common citations include:
- Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
- Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
- Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Both companies cited were involved in either Food and Cosmetics, Drugs, or Veterinary sectors.
Both companies cited should take voluntary actions to correct their managing operations.
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| American Regent, Inc. | Drugs | 04/24/2024 | Air Supply |
| American Regent, Inc. | Drugs | 04/24/2024 | Environmental Monitoring System |
| American Regent, Inc. | Drugs | 04/24/2024 | Equipment Design, Size and Location |
| American Regent, Inc. | Drugs | 04/24/2024 | Computer control of master formula records |
| American Regent, Inc. | Drugs | 04/24/2024 | Absence of Written Procedures |
| American Regent, Inc. | Drugs | 04/24/2024 | Validation lacking for sterile drug products |
| American Regent, Inc. | Drugs | 04/24/2024 | Storage under appropriate conditions |
| American Regent, Inc. | Veterinary | 04/24/2024 | Air Supply |
| American Regent, Inc. | Veterinary | 04/24/2024 | Environmental Monitoring System |
| American Regent, Inc. | Veterinary | 04/24/2024 | Equipment Design, Size and Location |
| American Regent, Inc. | Veterinary | 04/24/2024 | Computer control of master formula records |
| American Regent, Inc. | Veterinary | 04/24/2024 | Absence of Written Procedures |
| American Regent, Inc. | Veterinary | 04/24/2024 | Validation lacking for sterile drug products |
| American Regent, Inc. | Veterinary | 04/24/2024 | Storage under appropriate conditions |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | Personnel |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | Pest control |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | Sanitation of non-food-contact surfaces - Manner and frequency |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | Food safety plan |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | Hazard analysis |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | No HACCP plan |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | HACCP training or qualification |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | Sanitation Records |
| Optima Foods, Inc. | Food and Cosmetics | 04/11/2024 | Importer verification |
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