There were eight companies in cities associated with Seminole County that received FDA citations as a result of eight inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
- Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.
- Quality audits have not been performed.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Devices sector.
Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).
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 |
|---|---|---|---|
| Dilip Ceramics, Inc. | Food and Cosmetics | 04/09/2025 | Qualifications of individuals |
| Dilip Ceramics, Inc. | Food and Cosmetics | 04/09/2025 | Food safety plan |
| Dilip Ceramics, Inc. | Food and Cosmetics | 04/09/2025 | Recall plan – Written |
| Hill Dermaceuticals, Inc. | Drugs | 10/14/2025 | Buildings not maintained in good state of repair |
| Hill Dermaceuticals, Inc. | Drugs | 10/14/2025 | Cleaning / Sanitizing / Maintenance |
| Hill Dermaceuticals, Inc. | Drugs | 10/14/2025 | Calibration – at intervals, written program, remedial action |
| Hill Dermaceuticals, Inc. | Drugs | 10/14/2025 | Systems in place to comply with verification requirements |
| Hill Dermaceuticals, Inc. | Drugs | 10/14/2025 | Enhanced systems – verification |
| Macrocap Laboratories, LLC | Food and Cosmetics | 10/16/2025 | Specifications met – verify; finished batch |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Lack of System for Determining MDR Events |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Management ensuring quality policy is understood |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Quality Audit/Reaudit – conducted |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Change records, content |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Purchasing controls, Lack of or inadequate procedures |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Lack of or inadequate procedures |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Lack of or inadequate complaint procedures |
| Nutrex Research, Inc. | Food and Cosmetics | 12/03/2025 | Written procedures – establish; quality control operations |
| Nutrex Research, Inc. | Food and Cosmetics | 12/03/2025 | Quality control operations – packaging, labeling; approving, rejecting |
| Nutrex Research, Inc. | Food and Cosmetics | 12/03/2025 | Sampling plans; establish, follow |
| Nutrex Research, Inc. | Food and Cosmetics | 12/03/2025 | Make and keep records – returned dietary supplements |
| Radiant Pharma, LLC | Food and Cosmetics | 04/24/2025 | Equipment – controls, intended use |
| Radiant Pharma, LLC | Food and Cosmetics | 04/24/2025 | Component – qualify supplier |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Label to bear a unique device identifier |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Lack of Written MDR Procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Management review – Lack of or inadequate procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Quality System Procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Quality audits – Lack of or inadequate procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Training – Lack of or inadequate procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Design control – no procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Design Validation – Risk analysis not performed/inadequate |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Purchasing controls, Lack of or inadequate procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Lack of or inadequate In-process acceptance procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Nonconforming product, Lack of or inadequate procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Lack of or inadequate procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Lack of or inadequate complaint procedures |
| Rini Technologies, Inc. | Devices | 08/08/2025 | Devices subject to device identification GUDID data submission requirements. |
| The Father’s Table, LLC | Food and Cosmetics | 02/13/2025 | Plant construction and design |
| The Father’s Table, LLC | Food and Cosmetics | 02/13/2025 | Sanitation preventive controls – Identify (Written) |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
