483
InvaDerm, Inc.FDA 483 - InvaDerm, Inc. - June 28, 2023
Record Details
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.
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ID · 774d1424-d73e-4bf4-8d03-1236e1205b8d