There were six companies in cities associated with Macomb County that received FDA citations as a result of seven inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 20% increase over the number of companies cited in the previous year.
Of the 22 citations issued, the most common citation was ‘You did not conduct and document or obtain documentation of one or more supplier verification activities before importing the food into the United States’.
Most of the companies cited were involved in the Food and Cosmetics sector.
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 |
|---|---|---|---|
| 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) |
| Lipari Foods Operating Company, LLC. | Food and Cosmetics | 02/06/2025 | HACCP plan implementation |
| McKeon Products, Inc. | Devices | 05/07/2025 | Lack of Written MDR Procedures |
| McKeon Products, Inc. | Devices | 05/07/2025 | Lack of or inadequate procedures |
| McKeon Products, Inc. | Devices | 05/07/2025 | Lack of or inadequate complaint procedures |
| Oras 2, Inc. | Food and Cosmetics | 05/05/2025 | Develop FSVP |
| Oras 2, Inc. | Food and Cosmetics | 05/05/2025 | Hazard analysis written |
| Oras 2, Inc. | Food and Cosmetics | 05/05/2025 | Document review entity’s hazard analysis |
| Oras 2, Inc. | Food and Cosmetics | 05/05/2025 | Verification activity before import, periodically |
| Oras 2, Inc. | Food and Cosmetics | 12/18/2025 | Verification activity before import, periodically |
| Variety Food Services, Inc. | Food and Cosmetics | 04/03/2025 | Sanitary operations – Plant maintenance |
| Variety Food Services, Inc. | Food and Cosmetics | 04/03/2025 | Process preventive controls – Appropriate (Adequate) |
| Variety Food Services, Inc. | Food and Cosmetics | 04/03/2025 | Sanitation preventive controls – Appropriate (Adequate) |
| Variety Food Services, Inc. | Food and Cosmetics | 04/03/2025 | Critical limits |
| Variety Food Services, Inc. | Food and Cosmetics | 04/03/2025 | Monitoring – adequacy |
| Variety Food Services, Inc. | Food and Cosmetics | 04/03/2025 | Signed and dated |
| Variety Food Services, Inc. | Food and Cosmetics | 04/03/2025 | Ongoing verification – complaints, calibration records |
| Variety Food Services, Inc. | Food and Cosmetics | 04/03/2025 | HACCP training or qualification |
