FDA 483 - InvaDerm, Inc. - June 28, 2023

An FDA inspection of InvaDerm, Inc. in Somerset, NJ, revealed significant deficiencies across laboratory, production, and quality control systems. The firm failed to adequately investigate out-of-specification results and maintain complete laboratory data, raising concerns about data integrity. Additionally, issues were noted with equipment qualification, process control procedures, and environmental monitoring, indicating a lack of robust quality oversight.