Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is a 100% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not make and keep records for your returned dietary supplement operations.
- For component(s) used in the manufacture of a dietary supplement, you did not establish necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and limits on contamination to ensure the quality of the dietary supplement.
- You did not establish product specifications for purity, strength and limits on contamination.
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 |
|---|---|---|---|
| EnerHealth Botanicals, LLC | Food and Cosmetics | 08/15/2024 | Make and keep records - returned dietary supplements |
| New Herb Health, LLC | Food and Cosmetics | 08/15/2024 | Specifications - components |
| New Herb Health, LLC | Food and Cosmetics | 08/15/2024 | Specifications - finished dietary supplement |
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