FDA 483 - InvaTech Pharma Solutions, LLC - December 28, 2017

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.