# FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - November 05, 2020

Source: https://www.globalkeysolutions.net/records/483/novel-laboratories-inc-dba-lupin-somerset/9907ffb3-8bee-4e52-898f-44353c6b0620

> FDA 483 for Novel Laboratories, Inc. d.b.a Lupin Somerset on November 05, 2020. 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: 2020-11-05
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Novel Laboratories, Inc. d.b.a LUPIN received a Form 483 citing significant deficiencies across its manufacturing and quality control operations. Key issues include widespread failures in equipment cleaning and maintenance, inadequate investigations into out-of-specification results and discrepancies, and a lack of adherence to written procedures for stability testing, cleaning validation, and process controls. The facility also exhibited poor building maintenance, insufficient controls for potent drug contamination, and deficiencies in laboratory instrument calibration and personnel training.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/ko-min/767a6604-9a34-49c7-8462-c763c2689f61)
- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

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

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