There were four companies in cities associated with Orange County that received FDA citations as a result of four inspections conducted in the county in September, according to the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- Complaint files are not adequately maintained.
- The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
- You did not develop an FSVP.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).
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 |
|---|---|---|---|
| Barohup, Inc. | Food and Cosmetics | 09/04/2025 | Hazard analysis written |
| Barohup, Inc. | Food and Cosmetics | 09/04/2025 | Supplier approval – document |
| Barohup, Inc. | Food and Cosmetics | 09/04/2025 | Continue to import, change activities |
| Barohup, Inc. | Food and Cosmetics | 09/04/2025 | Verification activity frequency |
| Barohup, Inc. | Food and Cosmetics | 09/04/2025 | Onsite audit |
| Barohup, Inc. | Food and Cosmetics | 09/04/2025 | Audit – food safety regulation, plan |
| Barohup, Inc. | Food and Cosmetics | 09/04/2025 | Corrective actions – take, document |
| Dios Del Maiz Yun Katz Tortilleria | Food and Cosmetics | 09/23/2025 | Qualifications of individuals |
| Dios Del Maiz Yun Katz Tortilleria | Food and Cosmetics | 09/23/2025 | Personnel |
| Dios Del Maiz Yun Katz Tortilleria | Food and Cosmetics | 09/23/2025 | Cleaning and sanitizing substances – Safe and adequate |
| Dios Del Maiz Yun Katz Tortilleria | Food and Cosmetics | 09/23/2025 | Pest control |
| Dios Del Maiz Yun Katz Tortilleria | Food and Cosmetics | 09/23/2025 | Sanitation of food-contact surfaces – Frequency |
| Dios Del Maiz Yun Katz Tortilleria | Food and Cosmetics | 09/23/2025 | Sanitary facilities and controls |
| Dios Del Maiz Yun Katz Tortilleria | Food and Cosmetics | 09/23/2025 | Manufacturing, processing, packing, holding – Controls |
| Iherb, LLC | Food and Cosmetics | 09/24/2025 | Develop FSVP |
| Iherb, LLC | Food and Cosmetics | 09/24/2025 | Identification – entry |
| Syntech International, Inc. | Devices | 09/19/2025 | Complaints |
| Syntech International, Inc. | Devices | 09/19/2025 | GUDID Information required for unique device identification. |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
