FDA 483 - Carrollclean, LLC - August 31, 2023

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.