FDA 483 - AX Pharmaceutical Corporation - May 06, 2022

AX Pharmaceutical Corporation, a repackager, relabeler, and broker/trader of drug substances in Concord, Ontario, was cited for significant deficiencies across its quality system. Observations included inadequate record-keeping for API traceability, lack of quality unit oversight, deficient self-inspection programs, and unvalidated computerized systems. The firm also lacked essential written procedures for quality unit definition, complaint handling, API traceability, and qualification of outsourced service providers.