Carrollclean, LLCAugust 31, 2023

FDA 483 - Carrollclean, LLC - August 31, 2023

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Record Details

An FDA inspection of Carrollclean, LLC in Garland, TX, a manufacturer of Antimicrobial Hand Soap, revealed significant deficiencies in their quality system. Observations included failure to follow written production and process control procedures, leading to the release of out-of-specification product without proper justification. Additionally, the firm used uncalibrated test equipment, specifically a viscometer, to approve product for release.

Company: Carrollclean, LLC
Inspection Date: August 31, 2023
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
Person: Kevin T. Nguyen (investigator)

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ID · 951ea2a0-1b04-4ccb-b6ad-8309ed5300d5