How many companies in cities across Orange County received FDA citations in 2024?

How many companies in cities across Orange County received FDA citations in 2024?
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA — Official Website
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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.

Companies Located Within Orange County Cities and the Citations They Received in 2024
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


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