There were three companies in cities associated with Orange County that received FDA citations as a result of four inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 200% increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not take a reasonable measure or precaution related to personnel practices.
- You did not maintain your plant in a clean and sanitary condition and in adequate repair.
- Adequate toilet and washroom facilities for use of employees are not readily accessible adjacent to places and areas where land conveyances are serviced, maintained and cleaned.
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 |
|---|---|---|---|
| Equibal, Inc. | Drugs | 05/30/2024 | Procedures not in writing, fully followed |
| Equibal, Inc. | Drugs | 05/30/2024 | Equipment Design, Size and Location |
| Equibal, Inc. | Drugs | 05/30/2024 | Written procedures not established/followed |
| Equibal, Inc. | Drugs | 05/30/2024 | Calibration/Inspection/Checking not done |
| Equibal, Inc. | Drugs | 05/30/2024 | Handling and Storage to Prevent Contamination |
| Equibal, Inc. | Drugs | 05/30/2024 | Microscopic Exam of Components |
| Equibal, Inc. | Drugs | 05/30/2024 | Control procedures to monitor and validate performance |
| Equibal, Inc. | Drugs | 05/30/2024 | Lack of written stability program |
| Equibal, Inc. | Drugs | 05/30/2024 | Items to cover on annual reviews |
| Equibal, Inc. | Drugs | 05/30/2024 | Investigations of discrepancies, failures |
| Equibal, Inc. | Drugs | 05/30/2024 | Complaint Handling Procedure |
| Leprechaun Lines | Food and Cosmetics | 05/07/2024 | Adequate and readily accessible |
| Leprechaun Lines | Food and Cosmetics | 05/07/2024 | Equipment for cleaning and flushing |
| Leprechaun Lines | Food and Cosmetics | 12/18/2024 | Contamination of passenger stations |
| Leprechaun Lines | Food and Cosmetics | 12/18/2024 | Equipment for cleaning and flushing |
| Leprechaun Lines | Food and Cosmetics | 12/18/2024 | Sanitary sewers or alternative methods |
| Shimons Bakery, Inc. | Food and Cosmetics | 02/21/2024 | Personnel |
| Shimons Bakery, Inc. | Food and Cosmetics | 02/21/2024 | Sanitary operations – Plant maintenance |



