There were seven companies in cities associated with Charleston County that received FDA citations as a result of seven inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 16.7% increase over the number of companies cited in the previous year.
Of the 18 citations issued, the most common citation was ‘Your plant was not constructed and designed to facilitate maintenance and sanitary operations’.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%).
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 |
|---|---|---|---|
| Alcami Carolinas Corporation | Veterinary | 04/05/2024 | Following/documenting laboratory controls |
| Ashley Bakery | Food and Cosmetics | 03/13/2024 | Plant construction and design |
| Atlantic Grain and Trade, LLC | Veterinary | 07/10/2024 | Document review entity’s hazard analysis |
| Atlantic Grain and Trade, LLC | Veterinary | 07/10/2024 | Approved supplier procedures – importer established |
| Atlantic Grain and Trade, LLC | Veterinary | 07/10/2024 | Audit – food safety regulation, plan |
| Charlestowne Kettle Corn, LLC | Food and Cosmetics | 02/07/2024 | Plant construction and design |
| 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’s, Inc. | Food and Cosmetics | 08/22/2024 | Sanitary operations – Plant maintenance |
| Saffron’s, Inc. | Food and Cosmetics | 08/22/2024 | Pest control |
| Saffron’s, Inc. | Food and Cosmetics | 08/22/2024 | Sanitation of food-contact surfaces – Frequency |
| Saffron’s, Inc. | Food and Cosmetics | 08/22/2024 | Hazard analysis – Conducted |
| Specialty Blood Center | Biologics | 08/14/2024 | Record review prior to release |
| Specialty Blood Center | Biologics | 08/14/2024 | Test for HTLV, syphilis, West Nile, Chagas |
| Specialty Blood Center | Biologics | 08/14/2024 | CPR certification |
| Specialty Blood Center | Biologics | 08/14/2024 | Medical history and physical exam |
| Specialty Blood Center | Biologics | 08/14/2024 | Results of testing |
