FDA 483 - IntegraDose Compounding Services LLC - September 19, 2018
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The FDA Form 483 details multiple observations regarding a pharmaceutical facility's quality control and manufacturing practices.
**Key Violations and Observations:**
* **Inadequate Out-of-Specification (OOS) Investigations:** The firm failed to thoroughly investigate OOS results for several drug products, releasing batches based solely on retesting without identifying a laboratory error or root cause. * **Ephedrine Sulfate 25mg/5mL Syringe (Lot 20180228EPH-1):** Released despite a positive (b)(4) result (indicating possible microbiological contamination) without adequate sterility failure investigation. * **Hydromorphone Syringes (Multiple Lots):** Several lots (20171025HYD-1, 20171219HYD-1, 20180123HYD-2, 20180329HYD-2, 20180531HYD-1) were released with potency results outside specifications (e.g., 132.6%, 135.9%, 136.7%, 130.1%, 127.9%, 127.8%, 94.8%, 93.8%, 93.6%, 106.
ID · 37962bbd-499c-4159-897f-8284e6c1d6e6
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