Dermarite Industries, LLC. – FDA 483, Apr 8, 2025
Dermarite Industries, LLC. in North Bergen, NJ, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate stability programs, poor handling of out-of-specification results, insufficient complaint investigations, and a lack of proper process validation for OTC drug products. Additionally, issues with equipment cleaning, data integrity, and record retention were noted, indicating a systemic breakdown in GMP compliance.
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ID · 25eb2ca8-76f8-46c4-b96e-4c9bcf5bf544
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