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Wednesday, November 6, 2024

How many companies in cities across Delaware County received FDA citations in 2023?

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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

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

This is a 46.2% decrease from the number of companies cited in the previous year.

Of the 26 citations issued, the most common citations were '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' and 'Procedures for corrective and preventive action have not been adequately established'.

Most of the companies cited were involved in either Devices or Food and Cosmetics sectors.

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 Delaware County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Big Lots, Inc.Food and Cosmetics03/22/2023LACF compliance
Big Lots, Inc.Food and Cosmetics03/22/2023Hazard analysis written
Big Lots, Inc.Food and Cosmetics03/22/2023Supplier verification - establish written procedures
Big Lots, Inc.Food and Cosmetics03/22/2023Verification activity frequency
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
IncludeHealthDevices11/01/2023Management review - Lack of or inadequate procedures
IncludeHealthDevices11/01/2023Quality audits - Lack of or inadequate procedures
IncludeHealthDevices11/01/2023Design validation - software validation not performed
IncludeHealthDevices11/01/2023Lack of or inadequate procedures
IncludeHealthDevices11/01/2023Lack of or inadequate complaint procedures
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
Vesco Medical, LLCDevices10/31/2023Design control - no procedures
Vesco Medical, LLCDevices10/31/2023Purchasing controls, Lack of or inadequate procedures
Vesco Medical, LLCDevices10/31/2023Lack of or inadequate procedures
Vesco Medical, LLCDevices10/31/2023Investigation of device failures

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