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

James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer - Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer - Official Website
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There were four companies in cities associated with Fairfield 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 unchanged from the number of companies cited in the previous year.

The citations in the county include:

  • You did not have a written hazard analysis.
  • Your hazard analysis did not identify a hazard that requires a control.
  • You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier’s performance and the risk posed by a food.

Most of the companies cited were involved in the Devices 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 Fairfield County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
Calmare Therapeutics, Inc. Devices 05/22/2024 Lack of Written MDR Procedures
Calmare Therapeutics, Inc. Devices 05/22/2024 Management review – Lack of or inadequate procedures
Calmare Therapeutics, Inc. Devices 05/22/2024 Quality audits – Lack of or inadequate procedures
Calmare Therapeutics, Inc. Devices 05/22/2024 Design control – no procedures
Calmare Therapeutics, Inc. Devices 05/22/2024 Lack of or inadequate procedures
Calmare Therapeutics, Inc. Devices 05/22/2024 Lack of or inadequate complaint procedures
Charles Masson USA Food and Cosmetics 06/18/2024 Hazard analysis written
Charles Masson USA Food and Cosmetics 06/18/2024 Hazard analysis biological, chemical, physical
Charles Masson USA Food and Cosmetics 06/18/2024 Evaluation – performance, risk
Charles Masson USA Food and Cosmetics 06/18/2024 Evaluation, reevaluation – another entity
Charles Masson USA Food and Cosmetics 06/18/2024 Evaluation, reevaluation – qualified individual
Charles Masson USA Food and Cosmetics 06/18/2024 Approved supplier procedures – importer established
Charles Masson USA Food and Cosmetics 06/18/2024 Supplier verification – establish written procedures
Charles Masson USA Food and Cosmetics 06/18/2024 Verification activity assurance
Charles Masson USA Food and Cosmetics 06/18/2024 Verification activity frequency
Charles Masson USA Food and Cosmetics 06/18/2024 Verification activity before import, periodically
Charles Masson USA Food and Cosmetics 06/18/2024 Audit – document
Charles Masson USA Food and Cosmetics 06/18/2024 Verification activity review, assess
Charles Masson USA Food and Cosmetics 06/18/2024 Record – translate to English
CooperSurgical, Inc. Drugs 05/21/2024 Storage under appropriate conditions
Rapid Oxygen, Inc. Devices 04/26/2024 Documentation – review in response to changes or deviations
Rapid Oxygen, Inc. Devices 04/26/2024 Lack of or inadequate receiving acceptance procedures
Rapid Oxygen, Inc. Devices 04/26/2024 Lack of or inadequate procedures
Rapid Oxygen, Inc. Devices 04/26/2024 DHR – not or inadequately maintained


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