FDA 483 - PF Consumer Healthcare 1 LLC - April 01, 2019

The FDA inspection of PF Consumer Healthcare 1 LLC in Albany, GA, revealed significant deficiencies across its quality system, particularly in complaint handling and corrective actions. The firm failed to adequately investigate complaints, report adverse events in a timely manner, and control nonconforming products, leading to potential risks including burn injuries from their ThermaCare devices. These observations indicate a systemic breakdown in quality management and regulatory compliance, requiring comprehensive remediation.