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 50% decrease from the number of companies cited in the previous year.
The citations in the county include:
- You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.
- You did not prepare a batch production record every time you manufactured a batch of dietary supplement.
- You did not make and keep records of the written procedures for packaging and labeling operations.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| Source-Omega, LLC | Food and Cosmetics | 02/28/2024 | Reserve sample - collect, hold |
| Source-Omega, LLC | Food and Cosmetics | 02/28/2024 | Batch record - every batch |
| Source-Omega, LLC | Food and Cosmetics | 02/28/2024 | Records - packaging, labeling operations |
| Source-Omega, LLC | Food and Cosmetics | 02/28/2024 | Written procedures - product complaint; review, investigate |
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