There were two companies in a city associated with Macomb County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 33.3% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Your written allergen preventive control and monitoring procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control.
- Your written sanitation preventive control, monitoring and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
Both 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 |
|---|---|---|---|
| Femcap, Inc. | Devices | 08/08/2025 | Purchasing controls, Lack of or inadequate procedures |
| Femcap, Inc. | Devices | 08/08/2025 | Lack of or inadequate receiving acceptance procedures |
| Femcap, Inc. | Devices | 08/08/2025 | Nonconforming product, Lack of or inadequate procedures |
| JLM Manufacturing, LLC | Food and Cosmetics | 07/09/2025 | Allergen preventive controls – Appropriate (Adequate) |
| JLM Manufacturing, LLC | Food and Cosmetics | 07/09/2025 | Sanitation preventive controls – Appropriate (Adequate) |
