There were five companies in cities associated with Charleston County that received FDA citations as a result of five inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 37.5% decrease from the number of companies cited in the previous year.
Of the 32 citations issued, the most common citations include:
- Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
- Records of acceptable suppliers and contractors have not been established.
- There is no agreement with suppliers and contractors to notify you of changes in the product or service.
Most of the companies cited were involved in the Devices sector.
Of the companies cited, four should take voluntary actions to correct their managing operations (80%). Additionally, one company had to take regulatory and/or administrative actions (20%).
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Management review – defined interval, sufficient frequency |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Quality Audit/Reaudit – conducted |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Design plans – Lack of or inadequate |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Design validation – user needs and intended uses |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Purchasing controls, Lack of or inadequate procedures |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Acceptable supplier records, inadequate records |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Supplier notification of changes |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Lack of or inadequate final acceptance procedures |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | DHR documentation of label release {see also 820.184} |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | Records, DHR {see also 820.184(e)} |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | DMR device specifications |
| Auxilium Medical, Inc. | Devices | 03/26/2025 | DHR content |
| Capitol Coffee Systems, Inc. | Food and Cosmetics | 10/02/2025 | Modified requirement: Temperature control – Implement |
| Carolina Seafoods, Inc. | Food and Cosmetics | 05/02/2025 | HACCP plan implementation |
| Carolina Seafoods, Inc. | Food and Cosmetics | 05/02/2025 | Food safety hazards |
| Carolina Seafoods, Inc. | Food and Cosmetics | 05/02/2025 | Corrective action plan |
| Carolina Seafoods, Inc. | Food and Cosmetics | 05/02/2025 | Calibration – adequacy |
| Carolina Seafoods, Inc. | Food and Cosmetics | 05/02/2025 | Sanitation monitoring documentation |
| Horizon Scientific | Devices | 04/18/2025 | Procedures not adequately established or maintained |
| Horizon Scientific | Devices | 04/18/2025 | Supplier notification of changes |
| Horizon Scientific | Devices | 04/18/2025 | Servicing – Lack of or inadequate procedures |
| Vayuclear, Inc. | Devices | 03/14/2025 | Design plans – Lack of or inadequate |
| Vayuclear, Inc. | Devices | 03/14/2025 | Design output – documentation |
| Vayuclear, Inc. | Devices | 03/14/2025 | Design validation – documentation |
| Vayuclear, Inc. | Devices | 03/14/2025 | Documented evaluation |
| Vayuclear, Inc. | Devices | 03/14/2025 | Acceptable supplier records, inadequate records |
| Vayuclear, Inc. | Devices | 03/14/2025 | Lack of or inadequate final acceptance procedures |
| Vayuclear, Inc. | Devices | 03/14/2025 | Lack of or inadequate procedures |
| Vayuclear, Inc. | Devices | 03/14/2025 | Labeling inspection – UDI |
| Vayuclear, Inc. | Devices | 03/14/2025 | Records, DHR {see also 820.184(e)} |
| Vayuclear, Inc. | Devices | 03/14/2025 | Availability |
| Vayuclear, Inc. | Devices | 03/14/2025 | DHR – not or inadequately maintained |
