Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 33.3% decrease from the number of companies cited in the previous year.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- Aseptic processing areas are deficient in that walls are not smooth and/or hard surfaces that are easily cleanable.
- Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
The companies cited were involved in either Veterinary or Devices 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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Stryker Medical Division of Stryker Corporation | Devices | 11/15/2024 | Design verification - Lack of or inadequate procedures |
| Stryker Medical Division of Stryker Corporation | Devices | 11/15/2024 | Lack of or inadequate process validation |
| Zoetis, LLC | Veterinary | 02/13/2024 | Procedures not in writing, fully followed |
| Zoetis, LLC | Veterinary | 02/13/2024 | Floors, walls, ceiling surfaces |
| Zoetis, LLC | Veterinary | 02/13/2024 | Equipment Design, Size and Location |
| Zoetis, LLC | Veterinary | 02/13/2024 | Absence of Written Procedures |
| Zoetis, LLC | Veterinary | 02/13/2024 | Procedures for sterile drug products |
| Zoetis, LLC | Veterinary | 02/13/2024 | Investigations of discrepancies, failures |
| Zoetis, LLC | Veterinary | 02/13/2024 | Complete Test Data |
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