DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is an increase over the number of companies cited in the previous month.
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.
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 |
|---|---|---|---|
| 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 |
Alerts Sign-up