Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistAmerican Cleaning Solutions received a warning letter for failing to comply with Current Good Manufacturing Practice (CGMP) regulations while manufacturing over-the-counter hand sanitizer drug products. FDA inspectors found that the company failed to establish and follow written procedures for cleaning and maintenance of equipment and manufactured drugs using the same equipment as pesticides and industrial cleaners, creating unacceptable cross-contamination risks. The company's response to FDA's initial findings was deemed inadequate for lack of sufficient corrective action details, though the firm subsequently committed to ceasing hand sanitizer drug product manufacturing permanently and deregistering its operations.