FDA 483 - Sarepta Therapeutics Inc - March 24, 2023

An FDA inspection of Sarepta Therapeutics, Inc.'s biological drug testing lab in Andover, MA, revealed significant deficiencies in its quality control unit. The firm failed to timely investigate errors related to drug product stability, reference material, and release testing, leaving multiple quality events unresolved. Additionally, there was no written procedure for trending method failures, and a critical potency method exhibited a high failure rate.