Company
United StatesNovel Laboratories, Inc. d.b.a Lupin Somerset, Somerset, NJ – FDA Inspections
Inspection records and compliance data for Novel Laboratories, Inc. d.b.a Lupin Somerset in Somerset, New Jersey. 19 FDA inspections on record (1 OAI), 8 Form 483s, 1 warning letter, last inspected April 17, 2026.
Company Profile
This profile covers Novel Laboratories, Inc. d.b.a Lupin Somerset based in Somerset, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 19
- OAI
- 1
- VAI
- 11
- NAI
- 3
- Unclassified
- 4
- Form 483s
- 8
- Warning letters
- 1
First inspected March 5, 2010. Last inspected April 17, 2026.
Most cited issue areas
- Procedures not in writing, fully followed4 inspections
- Defined areas of adequate size for operations3 inspections
- Equipment Design, Size and Location2 inspections
FDA inspections (19)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 17, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1306616 |
| October 10, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1285934 |
| January 31, 2025 | Not classified | Human Drugs | 1259938 |
| May 17, 2024 | VAI | Human Drugs · Generic Drug Evaluation | 1235495 |
| January 13, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1197049 |
| March 30, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1168160 |
| November 5, 2020 | OAI | Human Drugs · Drug Quality Assurance | 1133661 |
| December 21, 2018 | Not classified | Human Drugs · Drug Quality Assurance | 1075292 |
| November 8, 2018 | VAI | Human Drugs · Bioresearch Monitoring | 1071709 |
| February 23, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1042022 |
| November 3, 2017 | Not classified | Human Drugs | 1037820 |
| August 8, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1020935 |
| February 14, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1002396 |
| November 17, 2015 | NAI | Human Drugs · Drug Quality Assurance | 949303 |
| January 22, 2015 | NAI | Human Drugs · Bioresearch Monitoring | 910801 |
| June 24, 2014 | VAI | Human Drugs · Drug Quality Assurance | 882621 |
| August 26, 2013 | VAI | Human Drugs · Drug Quality Assurance | 845686 |
| June 29, 2011 | VAI | Human Drugs · Drug Quality Assurance | 732416 |
| March 5, 2010 | VAI | Human Drugs · Drug Quality Assurance | 649639 |
FDA documents
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Novel Laboratories, Inc. d.b.a Lupin Somerset
FEI Number
3006271438
Address
400 Campus Dr, Somerset, New Jersey 08873, United States
Country
United States
ID: 53a42119-c077-49fb-b739-db29c2b99391