There were seven companies in cities associated with Montgomery County that received FDA citations as a result of seven 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 22.2% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.
- You did not document your review and assessment of a hazard analysis conducted by another entity and that a hazard analysis conducted by another entity was conducted by a qualified individual.
- You did not have a written hazard analysis.
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 |
|---|---|---|---|
| Alphorn | Food and Cosmetics | 04/30/2025 | Food safety plan |
| Canels USA 12, LLC | Food and Cosmetics | 04/14/2025 | Document review entity’s hazard analysis |
| El Maizito Tortilleria, Inc. | Food and Cosmetics | 06/11/2025 | Plant construction and design |
| El Maizito Tortilleria, Inc. | Food and Cosmetics | 06/11/2025 | Sanitary operations – Plant maintenance |
| El Maizito Tortilleria, Inc. | Food and Cosmetics | 06/11/2025 | Cleaning and sanitizing substances – Safe and adequate |
| El Maizito Tortilleria, Inc. | Food and Cosmetics | 06/11/2025 | Toxic chemicals – Identified, held, stored |
| El Maizito Tortilleria, Inc. | Food and Cosmetics | 06/11/2025 | Pest control |
| El Maizito Tortilleria, Inc. | Food and Cosmetics | 06/11/2025 | Sanitation of food-contact surfaces – Frequency |
| F&S Produce West, LLC | Food and Cosmetics | 05/05/2025 | Food safety hazards |
| Gourmet Imports LP | Food and Cosmetics | 05/28/2025 | Develop FSVP |
| Gourmet Imports LP | Food and Cosmetics | 05/28/2025 | Supplier verification – establish written procedures |
| Gourmet Imports LP | Food and Cosmetics | 05/28/2025 | Verification activity assurance |
| Gourmet Imports LP | Food and Cosmetics | 05/28/2025 | Verification activity before import, periodically |
| La Juna, Inc. | Food and Cosmetics | 05/09/2025 | Hazard analysis written |
| La Juna, Inc. | Food and Cosmetics | 05/09/2025 | Supplier verification – establish written procedures |
| La Juna, Inc. | Food and Cosmetics | 05/09/2025 | Supplier verification assurance |
| Truemed Group, LLC | Devices | 04/28/2025 | Lack of Written MDR Procedures |
| Truemed Group, LLC | Devices | 04/28/2025 | Design history file |
| Truemed Group, LLC | Devices | 04/28/2025 | Software validation for automated processes |
| Truemed Group, LLC | Devices | 04/28/2025 | Distribution records |
