There were 17 companies in cities associated with Orange County that received FDA citations as a result of 17 inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 54.1% decrease from the number of companies cited in the previous quarter.
Of the 56 citations issued, the most common citation was ‘You did not exclude pests from your food plant to protect against contamination of 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.
Of the companies cited, 16 should take voluntary actions to correct their managing operations (94.1%). Additionally, one company had to take regulatory and/or administrative actions (5.9%).
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 |
|---|---|---|---|
| 180 Snacks, Inc. | Food and Cosmetics | 07/16/2025 | Pest control |
| 180 Snacks, Inc. | Food and Cosmetics | 07/16/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| 180 Snacks, Inc. | Food and Cosmetics | 07/16/2025 | Manufacturing, processing, packing, holding – Controls |
| AME Foods, Inc. | Food and Cosmetics | 07/21/2025 | Sanitation monitoring |
| AME Foods, Inc. | Food and Cosmetics | 07/21/2025 | All hazards not considered |
| AME Foods, Inc. | Food and Cosmetics | 07/21/2025 | HACCP plan – critical limits not listed or not adequate |
| AME Foods, Inc. | Food and Cosmetics | 07/21/2025 | Verification – CCP, CA record review |
| AME Foods, Inc. | Food and Cosmetics | 07/21/2025 | HACCP plan – not validated |
| AME Foods, Inc. | Food and Cosmetics | 07/21/2025 | Records – actual values |
| AME Foods, Inc. | Food and Cosmetics | 07/21/2025 | Records – information not entered when observed |
| AME Foods, Inc. | Food and Cosmetics | 07/21/2025 | Records – computerized |
| 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 |
| C. H. Belt & Associates, Inc. | Food and Cosmetics | 07/17/2025 | Develop FSVP |
| C. H. Belt & Associates, Inc. | Food and Cosmetics | 07/17/2025 | Identification – entry |
| Calatex, Inc. | Devices | 08/27/2025 | Purchasing controls, Lack of or inadequate procedures |
| Calatex, Inc. | Devices | 08/27/2025 | Lack of or inadequate procedures |
| Chi’s Enterprise, Inc. | Food and Cosmetics | 07/21/2025 | Specifications – finished dietary supplement |
| Chi’s Enterprise, Inc. | Food and Cosmetics | 07/21/2025 | Specifications met – verify; finished batch |
| Design Catapult Manufacturing, Inc. | Devices | 08/19/2025 | Documentation |
| 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 |
| Koia Anaheim Facility, LLC | Food and Cosmetics | 07/25/2025 | Hazard analysis – Identification of hazard |
| La Habra Bakery | Food and Cosmetics | 08/07/2025 | Sanitary operations – Plant maintenance |
| La Habra Bakery | Food and Cosmetics | 08/07/2025 | Pest control |
| La Habra Bakery | Food and Cosmetics | 08/07/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| North American Science Associates, LLC | Drugs | 07/24/2025 | Environmental Monitoring System |
| North American Science Associates, LLC | Drugs | 07/24/2025 | Equipment to control conditions |
| North American Science Associates, LLC | Drugs | 07/24/2025 | Records not made readily available to FDA |
| North American Science Associates, LLC | Drugs | 07/24/2025 | Records reviewed annually |
| North American Science Associates, LLC | Drugs | 07/24/2025 | Investigations of discrepancies, failures |
| S. K. Laboratories, Inc. | Food and Cosmetics | 07/22/2025 | Hygienic practices |
| S. K. Laboratories, Inc. | Food and Cosmetics | 07/22/2025 | Criteria for establishing specifications |
| Sota Precison Optics, Inc. | Devices | 08/15/2025 | Lack of or inadequate final acceptance procedures |
| Sota Precison Optics, Inc. | Devices | 08/15/2025 | Lack of or inadequate procedures |
| Sota Precison Optics, Inc. | Devices | 08/15/2025 | Lack of or inadequate complaint procedures |
| Syntech International, Inc. | Devices | 09/19/2025 | Complaints |
| Syntech International, Inc. | Devices | 09/19/2025 | GUDID Information required for unique device identification. |
| Twenty1 Laboratories, Corp. | Food and Cosmetics | 07/23/2025 | Equipment – automated – calibrate, inspect |
| Twenty1 Laboratories, Corp. | Food and Cosmetics | 07/23/2025 | Specifications – finished dietary supplement |
| Twenty1 Laboratories, Corp. | Food and Cosmetics | 07/23/2025 | Component – verify identity, dietary ingredient |
| Twenty1 Laboratories, Corp. | Food and Cosmetics | 07/23/2025 | Component – qualify supplier |
| Vitabest Nutrition, Inc. | Food and Cosmetics | 07/18/2025 | Hygienic practices |
| Vitabest Nutrition, Inc. | Food and Cosmetics | 07/18/2025 | Batch record – required information |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
