# FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - March 30, 2022

Source: https://www.keypedia.com/records/483/novel-laboratories-inc-dba-lupin-somerset/d2442992-2045-48b7-a2c8-31301ba9b7c1

> FDA 483 for Novel Laboratories, Inc. d.b.a Lupin Somerset on March 30, 2022. Product: N/A. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Novel Laboratories, Inc. d.b.a Lupin Somerset
- Inspection Date: 2022-03-30
- Office Name: New Jersey District Office
- Summary: The FDA Form 483 details numerous deficiencies observed during an inspection of a drug manufacturing facility. The facility failed to thoroughly review unexplained discrepancies and out-of-specification batches. The qualification of a contract packager for (b)(4) Tablets was not documented, and SAP discrepancy investigations were not evaluated within the Quality system. Procedures for raw data document issuance and reconciliation were absent. Scientific justification for not performing microbial testing on (b)(4) Tablets and (b)(4) Capsules was not provided. Change controls for multiple documents lacked sufficient detail for adequate evaluation. The implementation of 100% cleaning verification on non-dedicated equipment was not handled through a Quality System. Procedures for handling drug product complaints were not written or followed, and employees lacked required training. Equipment cleaning and maintenance procedures were deficient in detail, and cleaning gaps of up to 14 days were noted for liquid manufacturing tanks. A logbook indicated cleaning started after manufacturing on 2/24/2022, but the walkthrough was on 3/7/2022. Supporting documentation for method validation (MVP-SOAP-CLN-LC and MVR-SOAP-CLN-LC from 2007) was unavailable. Written procedures for equipment cleaning and maintenance were not established or followed. Equipment design was not appropriate for intended use, and a 100% check-weigher (ID No. 2017) was not adequately qualified or calibrated

## Related Documents

- [483 - 2018-12-21](https://www.keypedia.com/records/483/novel-laboratories-inc-dba-lupin-somerset/340a2fdf-3c8d-4b48-b06d-a8bd3e42146e)
- [483 - 2020-11-05](https://www.keypedia.com/records/483/novel-laboratories-inc-dba-lupin-somerset/9907ffb3-8bee-4e52-898f-44353c6b0620)
- [483 - 2020-11-05](https://www.keypedia.com/records/483/novel-laboratories-inc-dba-lupin-somerset/5b4aee89-c5fd-487d-89cc-dbac6cbe518e)
- [WARNING_LETTER - 2020-11-05](https://www.keypedia.com/records/warning_letter/novel-laboratories-inc-dba-lupin-somerset/8db1077e-e83a-4e3a-8141-a77b0e62df2c)
- [483 - 2023-01-13](https://www.keypedia.com/records/483/novel-laboratories-inc-dba-lupin-somerset/2dd544ba-ef47-4a02-8afc-afbe901915b8)

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)
- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.keypedia.com/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

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