# FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - October 10, 2025

Source: https://www.keypedia.com/records/483/novel-laboratories-inc-dba-lupin-somerset/b504ca40-96c7-4e92-badd-0df5d3642eea

> FDA 483 for Novel Laboratories, Inc. d.b.a Lupin Somerset on October 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novel Laboratories, Inc. d.b.a Lupin Somerset
- Inspection Date: 2025-10-10
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Novel Laboratories, Inc. d.b.a Lupin in Somerset, NJ, was inspected regarding its manufacturing operations. The inspection revealed deficiencies in design validation procedures for nasal delivery devices used in combination drug products. Specifically, the firm failed to conduct design validation testing under actual or simulated use conditions and had inadequate risk analysis activities, including issues with clinical subject matter expert involvement and unjustified severity reductions in risk management reports.

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## Related Officers

- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)
- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.keypedia.com/companies/novel-laboratories-inc-dba-lupin-somerset/53a42119-c077-49fb-b739-db29c2b99391

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