# FDA 483 - Dermarite Industries, LLC. - April 08, 2025

Source: https://www.globalkeysolutions.net/records/483/dermarite-industries-llc/25eb2ca8-76f8-46c4-b96e-4c9bcf5bf544

> FDA 483 for Dermarite Industries, LLC. on April 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dermarite Industries, LLC.
- Inspection Date: 2025-04-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2025-04-08](https://www.globalkeysolutions.net/records/warning_letter/dermarite-industries-llc/12575d56-cc1a-458f-bb84-3dfaa86f46c7)

## Related Officers

- [Annet R. Rajan](https://www.globalkeysolutions.net/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)

Company: https://www.globalkeysolutions.net/companies/dermarite-industries-llc/72e65a9b-c9c7-44e1-a73a-fd807ffb77d3

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248