FDA 483 - Logix Biosciences Inc. - September 20, 2021

NDAL Mfg Inc. was cited for significant deficiencies in its quality control unit, including a lack of written procedures, agreements, and specifications with contract service providers. The inspection also revealed failures in documenting product failure investigations, establishing adequate stability testing for product expiration dates, and maintaining a robust system for product recalls and distribution records. These issues indicate a systemic lack of adherence to current good manufacturing practices.