FDA 483 - Honour Lab Limited - September 26, 2025

During an inspection conducted from September 22-26, 2025, the FDA issued a Form 483 to Honour Lab Limited, citing significant failures within its quality unit. The primary concern was the company's failure to ensure materials and samples, including Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) intended for the U.S. market, were tested solely at registered and qualified laboratories, and stored in disclosed and qualified warehouses. Specifically, FDA investigators observed numerous API and KSM samples from Honour Lab facilities, including Unit III, being tested at an unregistered and unqualified laboratory. Additionally, a substantial quantity of KSM was found stored at an undisclosed and unqualified warehouse. The company lacked essential quality agreements with both the unregistered testing facility and the undisclosed storage location. Furthermore, there was a documented instance of missing quantities in stability samples and undocumented resampling activities, with samples transported to the unregistered lab without proper records. The Corporate Quality Head's statements contradicting these observations highlighted a severe lack of oversight and control. These observations indicate critical deviations from Good Manufacturing Practices (GMP). Honour Lab Limited is required to implement comprehensive corrective and preventive actions to rectify these quality unit failures, ensure material integrity, validate all testing and storage facilities, establish proper quality agreements, and maintain thorough documentation for all processes affecting product quality and regulatory compliance.