FDA 483 - LiquidCapsule Manufacturing, LLC - February 09, 2024

LiquidCapsule Manufacturing, LLC received an FDA Form 483 following an inspection from February 5-9, 2024. The inspection revealed significant concerns regarding the company's adherence to Current Good Manufacturing Practices (cGMP) for its Over-the-Counter (OTC) drug products. Key issues included a failure to establish written procedures for production and process controls, specifically lacking process validation, equipment qualification, and cleaning validation for OTC drugs. The quality control unit demonstrated inadequate vendor qualification, insufficient testing of raw materials for identity and potency, and a lack of finished product potency testing. Additionally, the quality unit did not consistently follow its own procedures for annual product reviews, change control, or comprehensive failure investigations, and lacked documented raw material release reviews. Drug products also lacked expiration dates supported by appropriate and ongoing stability data, as the firm relied on limited, outdated studies to extend expiration dates. Finally, procedures to prevent objectionable microorganisms in non-sterile drug products were found to be inadequate, highlighted by an unvalidated water system with insufficient monitoring and sanitization. LiquidCapsule Manufacturing, LLC is required to address these observations by implementing comprehensive corrective actions and providing a detailed response to the FDA to ensure compliance with federal regulations.