Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistBrenntag Great Lakes, LLC, a drug manufacturer, failed to establish adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)) while producing over-the-counter hand sanitizer products on the same non-dedicated equipment used for non-drug items like industrial chemicals and automotive brake parts cleaner. Despite stating in a previous inspection that they would discontinue use of non-dedicated blending tanks for drug manufacturing, the company continued this practice, citing a failure to effectively communicate the decision to the production team. The FDA determined the firm's drugs were adulterated due to non-conformance with Current Good Manufacturing Practice regulations, and the company's response to the Form FDA 483 was deemed inadequate for lacking sufficient detail and evidence of corrective actions necessary to achieve compliance.