There were three companies in cities associated with Shelby County that received FDA citations as a result of three inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 62.5% decrease from the number of companies cited in the previous year.
The citations in the county include:
- You did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
- Your hazard analysis did not identify a hazard that required a preventive control.
- You did not implement your other monitoring and verification procedures.
All of the companies cited were involved in either Biologics, Food and Cosmetics, or Devices sectors.
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.
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 |
|---|---|---|---|
| Alabama Center for Reproductive Medicine | Biologics | 09/15/2025 | Testing, screening, donor eligibility procedures |
| Better Kombucha | Food and Cosmetics | 10/15/2025 | Hazard analysis – Identification of hazard |
| Better Kombucha | Food and Cosmetics | 10/15/2025 | Other preventive controls – Implement |
| Better Kombucha | Food and Cosmetics | 10/15/2025 | Sanitation preventive controls – Implementation records |
| Folsom Metal Products, Inc. | Devices | 08/01/2025 | Lack of or inadequate organizational structure |
| Folsom Metal Products, Inc. | Devices | 08/01/2025 | Lack of or inadequate process validation |
| Folsom Metal Products, Inc. | Devices | 08/01/2025 | Nonconforming product, Lack of or inadequate procedures |
| Folsom Metal Products, Inc. | Devices | 08/01/2025 | Lack of or inadequate procedures |
