FDA 483 - Dermarite Industries, LLC. - April 08, 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.