Xellia Pharmaceuticals USA LLC – FDA 483, Feb 7, 2022
An FDA inspection of Xellia Pharmaceuticals USA LLC in Bedford, OH, a manufacturer of sterile drug products, revealed a significant lapse in quality control unit procedures. The firm failed to submit a field alert report within the required three-day timeframe following notification of an out-of-specification stability result for a distributed batch of Vancomycin Hydrochloride for Injection USP. This delay indicates a failure to adhere to established internal procedures for critical product quality issues.
ID · 2f5255cd-c4f9-46a6-aad5-f2c327bae925
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