# FDA 483 - Neutraderm Inc. - June 15, 2026

Source: https://www.keypedia.com/records/483/neutraderm-inc/c85d6da4-f8d5-4308-b0fd-302a1daecbff

> FDA 483 for Neutraderm Inc. on June 15, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Neutraderm Inc.
- Inspection Date: 2026-06-15
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Neutraderm, Inc. in Chatsworth, CA, a drug manufacturer, was cited for significant deficiencies across its quality system and laboratory controls. The inspection revealed inadequate investigations into out-of-specification results, customer complaints, and defective materials, alongside issues with equipment qualification and cleaning logs. Further observations included a lack of proper contamination testing, incomplete annual product reviews, outdated cleaning validation, and failures in issuing authentic Certificates of Analysis for repacked APIs.

## Related Documents

- [483 - 2022-12-09](https://www.keypedia.com/records/483/neutraderm-inc/146ec208-c6bd-4d51-9af4-f45764492bae)

## Related Officers

- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)
- [Sara H. Gabel](https://www.keypedia.com/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)

Company: https://www.keypedia.com/companies/neutraderm-inc/b30fa543-50d4-4638-94cd-448e5c4afc87

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b