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 quarter.
The citations in the county include:
- HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend and a statement warning of the reactive test results.
- The abbreviated donor screening procedure was used for donors who had no complete donor screening procedure in the previous six months.
- A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established.
Both companies cited were involved in either Biologics or Food and Cosmetics sectors.
Both 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 |
|---|---|---|---|
| Piedmont Reproductive Endocrinology Associates Lowcountry | Biologics | 08/07/2024 | Labeled re: biohazard, risks, test results |
| Piedmont Reproductive Endocrinology Associates Lowcountry | Biologics | 08/07/2024 | Abbreviated procedure |
| Piedmont Reproductive Endocrinology Associates Lowcountry | Biologics | 08/07/2024 | SOP for release; reactive for CMV |
| Saffron, Inc. | Food and Cosmetics | 08/22/2024 | Sanitary operations - Plant maintenance |
| Saffron, Inc. | Food and Cosmetics | 08/22/2024 | Pest control |
| Saffron, Inc. | Food and Cosmetics | 08/22/2024 | Sanitation of food-contact surfaces - Frequency |
| Saffron, Inc. | Food and Cosmetics | 08/22/2024 | Hazard analysis - Conducted |
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