InvaTech Pharma Solutions, LLC – FDA 483, Jun 9, 2023

InvaTech Pharma Solutions, LLC, a contract manufacturer and repacker in East Brunswick, NJ, received eight observations during an FDA inspection from June 5-9, 2023. The firm was cited for significant deficiencies in its quality system, including inadequate investigations into out-of-specification results and customer complaints, and a lack of process validation. Additional concerns involved insufficient sampling plans, deficient equipment cleaning procedures, improper storage conditions for materials and products, and uncontrolled access to labeling materials.