There were 16 companies in cities associated with Montgomery County that received FDA citations as a result of 16 inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 20% decrease from the number of companies cited in the previous quarter.
Of the 36 citations issued, the most common citations include:
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
- You did not have a written hazard analysis.
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier’s performance and the risk posed by a food.
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.
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 |
|---|---|---|---|
| 5 Star Foods International, LLC | Food and Cosmetics | 07/16/2025 | Hazard analysis written |
| 5 Star Foods International, LLC | Food and Cosmetics | 07/16/2025 | Evaluation – performance, risk |
| 5 Star Foods International, LLC | Food and Cosmetics | 07/16/2025 | Verification activity frequency |
| Ajuuua Distributors, LLC | Food and Cosmetics | 07/30/2025 | Develop FSVP |
| Ajuuua Distributors, LLC | Food and Cosmetics | 07/30/2025 | Identification – entry |
| Copan Trade, Ltd. | Food and Cosmetics | 07/18/2025 | Hazard analysis biological, chemical, physical |
| Copan Trade, Ltd. | Food and Cosmetics | 07/18/2025 | Verification activity before import, periodically |
| Fortune Fish & Gourmet, LLC | Food and Cosmetics | 08/12/2025 | HACCP plan implementation |
| Kalil Enterprise Corporation | Food and Cosmetics | 09/16/2025 | Develop FSVP |
| Kalil Enterprise Corporation | Food and Cosmetics | 09/16/2025 | Identification – entry |
| Lawrence Ginsberg, M.D. | Drugs | 07/29/2025 | FD-1572, protocol compliance |
| Meditco, Inc. | Food and Cosmetics | 09/03/2025 | Hazard analysis biological, chemical, physical |
| Meditco, Inc. | Food and Cosmetics | 09/03/2025 | Verification activity before import, periodically |
| Millar, Inc. | Devices | 07/01/2025 | Quality Audits – defined intervals |
| Millar, Inc. | Devices | 07/01/2025 | Equipment control activity documentation |
| Millar, Inc. | Devices | 07/01/2025 | Lack of or inadequate receiving acceptance procedures |
| Millar, Inc. | Devices | 07/01/2025 | Lack of or inadequate complaint procedures |
| Rasaraga International, LLC | Food and Cosmetics | 07/10/2025 | Cleaning and sanitizing substances – Safe and adequate |
| Riviana Foods, Inc. | Food and Cosmetics | 08/22/2025 | Hazard analysis written |
| Riviana Foods, Inc. | Food and Cosmetics | 08/22/2025 | Evaluation – performance, risk |
| Riviana Foods, Inc. | Food and Cosmetics | 08/22/2025 | Supplier verification – follow written procedures |
| Riviana Foods, Inc. | Food and Cosmetics | 08/22/2025 | Supplier verification assurance |
| Riviana Foods, Inc. | Food and Cosmetics | 08/22/2025 | Verification activity adequate assurance |
| Salata Dressings, LLC | Food and Cosmetics | 07/09/2025 | Hazard analysis – Identification of hazard |
| Salata Dressings, LLC | Food and Cosmetics | 07/09/2025 | Sanitation preventive controls – Implement |
| Seafood Wholesalers, Limited | Food and Cosmetics | 08/28/2025 | Corrective action plan |
| Seafood Wholesalers, Limited | Food and Cosmetics | 08/28/2025 | Corrective action per predetermined plan |
| Seafood Wholesalers, Limited | Food and Cosmetics | 08/28/2025 | Sanitation monitoring |
| Sivon International | Food and Cosmetics | 09/04/2025 | Importer verification |
| Southern Gulf Packaging & Logistics, LLC | Food and Cosmetics | 07/25/2025 | Food safety plan |
| UIH Technologies, LLC | Devices | 08/20/2025 | Form of a unique device identifier |
| UIH Technologies, LLC | Devices | 08/20/2025 | Lack of or inadequate final acceptance procedures |
| UIH Technologies, LLC | Devices | 08/20/2025 | Lack of or inadequate complaint procedures |
| Wexler Surgical, Inc. | Devices | 07/30/2025 | Design validation- Lack of or inadequate procedures |
| Wexler Surgical, Inc. | Devices | 07/30/2025 | Design changes – Lack of or Inadequate Procedures |
| Wexler Surgical, Inc. | Devices | 07/30/2025 | Documentation |
