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 a 200% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.
- Failure to test each donation of blood and blood components intended for transfusion or for use in manufacturing a product for evidence of infection with HTLV and West Nile virus.
- Failure to assure that an individual who is currently certified in cardiopulmonary resuscitation is located on the premises whenever collections of blood or blood components are performed.
Most of the companies cited were involved in the Biologics 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 |
|---|---|---|---|
| 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 |
| Vitrologic, Inc. | Biologics | 08/14/2024 | Record review prior to release |
| Vitrologic, Inc. | Biologics | 08/14/2024 | Test for HTLV, syphilis, West Nile, Chagas |
| Vitrologic, Inc. | Biologics | 08/14/2024 | CPR certification |
| Vitrologic, Inc. | Biologics | 08/14/2024 | Medical history and physical exam |
| Vitrologic, Inc. | Biologics | 08/14/2024 | Results of testing |
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