Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 50% increase over the number of companies cited in the previous quarter.
Of the 22 citations issued, the most common citations were 'You did not maintain your plant in adequate repair' and 'Your hazard analysis did not identify a hazard that required a preventive control'.
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Dairy Manufacturers, Inc. | Food and Cosmetics | 02/20/2025 | Approved supplier procedures - importer established |
| Dairy Manufacturers, Inc. | Food and Cosmetics | 02/21/2025 | Hazard analysis - Identification of hazard |
| Dairy Manufacturers, Inc. | Food and Cosmetics | 02/21/2025 | Process preventive controls - Appropriate (Adequate) |
| Delasco, Inc. | Devices | 01/14/2025 | Lack of Written MDR Procedures |
| Delasco, Inc. | Devices | 01/14/2025 | Lack of or inadequate procedures - Acceptance activities |
| Delasco, Inc. | Devices | 01/14/2025 | Lack of or inadequate procedures |
| Delasco, Inc. | Devices | 01/14/2025 | Lack of or inadequate complaint procedures |
| Emanuel Distributors | Food and Cosmetics | 01/13/2025 | Qualifications of individuals |
| Emanuel Distributors | Food and Cosmetics | 01/13/2025 | Food safety plan |
| Gate Gourmet, Inc. | Food and Cosmetics | 02/04/2025 | Sanitary operations - Plant maintenance |
| Gate Gourmet, Inc. | Food and Cosmetics | 02/04/2025 | Sanitary facilities and controls |
| Gate Gourmet, Inc. | Food and Cosmetics | 02/04/2025 | Process preventive controls - Appropriate (Adequate) |
| John Hogan Interests | Food and Cosmetics | 02/25/2025 | Hazard analysis - Identification of hazard |
| Metro Optics, Inc. | Devices | 03/17/2025 | Procedures not adequately established or maintained |
| North Food Group, Inc. | Food and Cosmetics | 02/13/2025 | Sanitary operations - Plant maintenance |
| North Food Group, Inc. | Food and Cosmetics | 02/13/2025 | Storage and Distribution |
| North Food Group, Inc. | Food and Cosmetics | 02/13/2025 | HACCP plan implementation |
| North Food Group, Inc. | Food and Cosmetics | 02/13/2025 | Food safety hazards |
| North Food Group, Inc. | Food and Cosmetics | 02/13/2025 | Verification procedures - adequacy |
| North Food Group, Inc. | Food and Cosmetics | 02/13/2025 | Verification - reviewers qualifications |
| Wisconsin's Finest, Inc. | Food and Cosmetics | 02/24/2025 | Modified requirement: Temperature control - Implement |
| iVu Imaging Corporation | Devices | 03/05/2025 | DHR content |
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