# FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - January 13, 2023

Source: https://www.keypedia.com/records/483/novel-laboratories-inc-dba-lupin-somerset/2dd544ba-ef47-4a02-8afc-afbe901915b8

> FDA 483 for Novel Laboratories, Inc. d.b.a Lupin Somerset on January 13, 2023. 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: 2023-01-13
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Novel Laboratories, Inc. d.b.a Lupin in Somerset, NJ, was inspected and received two observations related to manufacturing practices. The inspection revealed deficiencies in laboratory controls, specifically regarding the scientific justification for microbial testing procedures, and issues with equipment qualification and design for its intended use in drug product manufacturing. These findings indicate potential risks to drug product quality and purity.

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## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [Investigator](https://www.keypedia.com/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

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