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

Source: https://www.globalkeysolutions.net/records/483/invaderm-inc/774d1424-d73e-4bf4-8d03-1236e1205b8d

> FDA 483 for InvaDerm, Inc. on June 28, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: InvaDerm, Inc.
- Inspection Date: 2023-06-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [483 - 2024-10-17](https://www.globalkeysolutions.net/records/483/invaderm-inc/5dd5b4c4-7289-4c2a-afce-73112a714736)

## Related Officers

- [James R. Birkenstamm](https://www.globalkeysolutions.net/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.globalkeysolutions.net/companies/invaderm-inc/33416b4a-1d16-4adf-987e-d5970ac5f9a2

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