FDA 483 - Axogen Corp

Axogen Corporation, a manufacturer of AVANCE drug substance and drug product in Vandalia, OH, was cited for significant deficiencies across its manufacturing and quality systems. Observations included inadequate warehousing controls, a deficient environmental monitoring program, insufficient contamination prevention measures, and inadequate production and process control procedures. Additionally, the firm was cited for inadequate laboratory controls, deficient pest control investigations, and an ineffective deviation management system, indicating a broad lack of quality oversight.