There were nine companies in cities associated with Shelby County that received FDA citations as a result of nine inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- Required records are not stored to minimize deterioration and prevent loss and are not backed up when stored in automated data processing systems.
- Records of complaint investigations do not include required information.
- Procedures for corrective and preventive action have not been adequately established.
Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the the Food and Cosmetics sector.
Of the companies cited, seven should take voluntary actions to correct their managing operations (77.8%). Additionally, two companies had to take regulatory and/or administrative actions (22.2%).
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 |
|---|---|---|---|
| AB Mauri Foods, Inc. | Food and Cosmetics | 02/10/2023 | Personnel |
| AB Mauri Foods, Inc. | Food and Cosmetics | 02/10/2023 | Plant construction and design |
| AB Mauri Foods, Inc. | Food and Cosmetics | 02/10/2023 | Sanitary operations – Plant maintenance |
| AB Mauri Foods, Inc. | Food and Cosmetics | 02/10/2023 | Equipment and utensils – Design and maintenance |
| AB Mauri Foods, Inc. | Food and Cosmetics | 02/10/2023 | Process preventive controls – Appropriate (Adequate) |
| CE-Bio, LLC | Food and Cosmetics | 12/06/2023 | In-process identity, purity, strength, composition |
| CE-Bio, LLC | Food and Cosmetics | 12/06/2023 | Specifications – labels, packaging |
| CE-Bio, LLC | Food and Cosmetics | 12/06/2023 | Specifications – identity, purity, strength, composition |
| CE-Bio, LLC | Food and Cosmetics | 12/06/2023 | Quality control – dietary supplement; adulteration |
| CE-Bio, LLC | Food and Cosmetics | 12/06/2023 | Batch record – complete |
| Central States Foods, Inc. | Food and Cosmetics | 05/25/2023 | Toxic chemicals – Identified, held, stored |
| Cornerstone Laboratories, LLC | Drugs | 01/19/2023 | Procedures not in writing, fully followed |
| Cornerstone Laboratories, LLC | Drugs | 01/19/2023 | Training–operations, GMPs, written procedures |
| Cornerstone Laboratories, LLC | Drugs | 01/19/2023 | Computer control of master formula records |
| Cornerstone Laboratories, LLC | Drugs | 01/19/2023 | Calibration – at intervals, written program, remedial action |
| Cornerstone Laboratories, LLC | Drugs | 01/19/2023 | Complete Test Data |
| Edge Biologicals, Inc. | Devices | 04/04/2023 | Quality Audits – defined intervals |
| Edge Biologicals, Inc. | Devices | 04/04/2023 | Personnel |
| Edge Biologicals, Inc. | Devices | 04/04/2023 | Evaluation of suppliers, contractors, etc., requirements |
| Edge Biologicals, Inc. | Devices | 04/04/2023 | Environmental control Lack of or inadequate procedures |
| Edge Biologicals, Inc. | Devices | 04/04/2023 | Lack of or inadequate process validation |
| Edge Biologicals, Inc. | Devices | 04/04/2023 | Lack of or inadequate procedures – Acceptance activities |
| Edge Biologicals, Inc. | Devices | 04/04/2023 | Lack of or inadequate procedures |
| Edge Biologicals, Inc. | Devices | 04/04/2023 | DMR – not or inadequately maintained |
| Engineered Medical Systems, LLC | Devices | 02/10/2023 | Lack of or inadequate procedures |
| Matrix Machining Technologies, Inc. | Devices | 01/26/2023 | Quality audits – Lack of or inadequate procedures |
| Matrix Machining Technologies, Inc. | Devices | 01/26/2023 | Training – Lack of or inadequate procedures |
| Odyssey Medical Technologies, LLC. | Devices | 04/03/2023 | Records of complaint investigation |
| Somavac Medical Solutions, Inc. | Devices | 09/22/2023 | Availability |
