Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not establish label specifications.
- You did not follow written procedures for quality control operations.
- Your quality control personnel did not reject a component and dietary supplement when an established specification was not met.
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 |
---|---|---|---|
Premier Produce Services, LLC | Food and Cosmetics | 12/13/2024 | Hazard analysis written |
Premier Produce Services, LLC | Food and Cosmetics | 12/13/2024 | Verification activity before import, periodically |
Shield Bearer, Inc. | Food and Cosmetics | 10/17/2024 | Specifications - labels, packaging |
Shield Bearer, Inc. | Food and Cosmetics | 10/17/2024 | Written procedures - follow; quality control operations |
Shield Bearer, Inc. | Food and Cosmetics | 10/17/2024 | Quality control - reject; specification not met |