FDA 483 - Anika Therapeutics, Inc. - January 22, 2026
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Anika Therapeutics, Inc., a sterile drug manufacturer in Bedford, MA, was cited for significant quality control deficiencies during an FDA inspection. Observations included failures to investigate product discrepancies and implement CAPAs, inadequate computer system controls leading to potential data integrity issues, and premature release of sterile drug batches before media fill record approval. Additionally, the facility's aseptic processing areas had damaged surfaces that were not easily cleanable.
ID · 6ee0397c-b2e8-4c3d-b45d-dd3386d4b81d