483
InvaTech Pharma Solutions, LLCFDA 483 - InvaTech Pharma Solutions, LLC - December 28, 2017
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InvaTech Pharma Solutions, LLC in East Brunswick, NJ, received a Form 483 with three observations related to manufacturing and quality control. The firm failed to thoroughly investigate out-of-specification results, did not establish in-process hold times for drug products, and inconsistently calculated theoretical and actual yields, leading to uninvestigated out-of-trend results. These issues indicate deficiencies in their quality system and process control.
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