AX Pharmaceutical Corporation – FDA 483, May 6, 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.
ID · 2c4a5ed7-8c54-43c8-973e-89b683620bc2
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