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 200% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not conduct and document or obtain documentation of one or more supplier verification activities.
- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
- You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.
Most of the companies cited were involved in the Food and Cosmetics sector.
All of the 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 |
|---|---|---|---|
| B and A Trading Corporation | Food and Cosmetics | 02/14/2024 | Verification activity before import, periodically |
| Genzyme Corporation | Drugs | 03/18/2024 | Procedures for sterile drug products |
| Rudy's Inflight Catering | Food and Cosmetics | 03/26/2024 | Raw material control - Inspection |
| Rudy's Inflight Catering | Food and Cosmetics | 03/26/2024 | Manufacturing, processing, packing, holding - Controls |
| Rudy's Inflight Catering | Food and Cosmetics | 03/26/2024 | Food safety plan |
| Rudy's Inflight Catering | Food and Cosmetics | 03/26/2024 | No HACCP plan |
| Rudy's Inflight Catering | Food and Cosmetics | 03/26/2024 | Contamination |
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