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 an increase over the number of companies cited in the previous month.
The citations in the county include:
- You did not implement your sanitation preventive control, corrective action and verification procedures.
- You did not implement your written supply-chain program.
- Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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 |
|---|---|---|---|
| Fmklabs | Drugs | 12/31/2024 | Equipment Design, Size and Location |
| Fmklabs | Drugs | 12/31/2024 | Written in-process control procedures |
| Fmklabs | Drugs | 12/31/2024 | No written record of investigation |
| Fmklabs | Drugs | 12/31/2024 | Suitability of testing methods verified |
| Food For Life Baking Company, Inc. | Food and Cosmetics | 12/11/2024 | Sanitation preventive controls - Implement |
| Food For Life Baking Company, Inc. | Food and Cosmetics | 12/11/2024 | Supply-chain program - Implement |
| Ludford's, Inc. | Food and Cosmetics | 12/13/2024 | Sanitary operations - Plant maintenance |
| Ludford's, Inc. | Food and Cosmetics | 12/13/2024 | Sanitation of non-food-contact surfaces - Manner and frequency |
| Ludford's, Inc. | Food and Cosmetics | 12/13/2024 | Sanitary facilities and controls |
| Ludford's, Inc. | Food and Cosmetics | 12/13/2024 | HACCP plan - monitoring procedures not adequate |
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