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Thursday, November 28, 2024

FDA: 4 companies in cities within Fairfield County received 13 citations in 2023

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

There were four companies in a city associated with Fairfield County that received FDA citations as a result of four inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 69.2% decrease from the number of companies cited in the previous year.

Of the 13 citations issued, the most common citation was 'A qualified container closure inspection person did not record the observations made of the top seam of a can randomly selected from each seaming head and the container closures at intervals of sufficient frequency to ensure proper closure'.

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.

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, according to its website.

Companies Located Within Fairfield County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Dan the Baker, LLCFood and Cosmetics03/01/2023Personnel
Dan the Baker, LLCFood and Cosmetics03/01/2023Plant construction and design
Dan the Baker, LLCFood and Cosmetics03/01/2023Sanitary facilities and controls
GFS Chemicals, Inc.Devices11/17/2023Lack/Inad procedure-Monitoring/Control of Validated Proces
Mars Petcare US, Inc.Food and Cosmetics01/23/2023Frequency: visual closure examinations, record
Mars Petcare US, Inc.Veterinary01/23/2023Frequency: visual closure examinations, record
Safecor Health, LLCDrugs09/01/2023Identity Testing of Each Component
Safecor Health, LLCDrugs09/01/2023Absence of Written Procedures
Safecor Health, LLCDrugs09/01/2023Changes to Procedures Not Reviewed, Approved
Safecor Health, LLCDrugs09/01/2023Reprocessing/quality control unit
Safecor Health, LLCDrugs09/01/2023Sample size - test intervals
Safecor Health, LLCDrugs09/01/2023Written records kept in individual logs
Safecor Health, LLCDrugs09/01/2023Investigations of discrepancies, failures

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