FDA 483 - Medique Products - July 18, 2024
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UniFirst First Aid + Safety in Fort Myers, FL, was inspected from July 16-18, 2024, and received a Form 483. The inspection revealed significant deficiencies in the firm's quality control unit, specifically concerning the inspection and release of incoming finished OTC drug products, the receipt of Certificates of Analysis, and the retention of product samples. These issues indicate a failure to follow established procedures for ensuring product quality and compliance.
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