There were six companies in cities associated with Miami-Dade County that received FDA citations as a result of six inspections conducted in the county over the second quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 14.3% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- You did not establish product specifications for purity, strength, composition and limits on contamination.
- You did not make and keep records of established specifications, of your qualification of a supplier and for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets established specifications.
- You did not use effective measures to protect against the inclusion of metal or other foreign material in dietary supplements.
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 |
|---|---|---|---|
| All Over Import & Export, Inc. | Food and Cosmetics | 05/02/2025 | Personnel |
| Evi Labs | Food and Cosmetics | 05/02/2025 | Specifications – finished dietary supplement |
| Evi Labs | Food and Cosmetics | 05/02/2025 | Records – make and keep |
| Evi Labs | Food and Cosmetics | 05/02/2025 | Metal, foreign material |
| Evi Labs | Food and Cosmetics | 05/02/2025 | Manufacturing, processing, packing, holding – Controls |
| La Nica Products, Inc. | Food and Cosmetics | 06/11/2025 | Sanitary operations – Plant maintenance |
| Macbrud Corporation | Devices | 05/21/2025 | Supplier oversight |
| Macbrud Corporation | Devices | 05/21/2025 | Lack of or inadequate procedures – Acceptance activities |
| Tropical Key, Inc. | Food and Cosmetics | 05/08/2025 | Plant construction and design |
| Tropical Key, Inc. | Food and Cosmetics | 05/08/2025 | Equipment and utensils – Design and maintenance |
| Tropical Key, Inc. | Food and Cosmetics | 05/08/2025 | Plant operations – Precautions |
| Tropical Key, Inc. | Food and Cosmetics | 05/08/2025 | Manufacturing, processing, packing, holding – Controls |
| Trujillo Oil Plant, Inc. | Food and Cosmetics | 06/26/2025 | Sanitation monitoring |
| Trujillo Oil Plant, Inc. | Food and Cosmetics | 06/26/2025 | HACCP plan – critical limits not listed or not adequate |
