Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Accord USA has initiated recall of multiple lots of Atropine Sulfate, USP 8 mg per 20 mL injection & Bivalirudin for Injection 250 mg, manufactured by Intas Ahmedabad, for presence of particulate matter, fibers. An USFDA inspection in May 2023 at Intas Ahmedabad had made observations on particulate matter in injection vials, manipulated visual inspection records. Read Enforcement Report
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