Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.
- Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
- Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).
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 |
|---|---|---|---|
| Freelance Formulations, LLC | Drugs | 02/08/2023 | Approve or reject components, products |
| Freelance Formulations, LLC | Drugs | 02/08/2023 | Reports of Analysis (Components) |
| Freelance Formulations, LLC | Drugs | 02/08/2023 | Control procedures to monitor and validate performance |
| We Make Vitamins, LLC | Food and Cosmetics | 09/19/2023 | Equipment - controls - QC |
| We Make Vitamins, LLC | Food and Cosmetics | 09/19/2023 | Specifications-component purity, strength, composition |
| We Make Vitamins, LLC | Food and Cosmetics | 09/19/2023 | Specifications - identity, purity, strength, composition |
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