Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
- Quality audits were not performed at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
- Potential suppliers and contractors were not evaluated based on their ability to meet specified requirements.
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 |
|---|---|---|---|
| AFP Manufacturing | Devices | 05/31/2024 | Management review - defined interval, sufficient frequency |
| AFP Manufacturing | Devices | 05/31/2024 | Quality Audits - defined intervals |
| AFP Manufacturing | Devices | 05/31/2024 | Evaluation and Selection, Suppliers, Contractors, etc. |
| Hickling Feed, Inc. | Veterinary | 04/03/2024 | Contamination with Mycotoxins/Natural Toxins |
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