483
InvaTech Pharma Solutions, LLCFDA 483 - InvaTech Pharma Solutions, LLC - June 09, 2023
Record Details
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.
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ID · 72351d09-9e17-4f73-a196-2f7193d5627c