Novel Labs
United States 57 employees Updated 9 July 2026
Novel Labs is a finished-dose manufacturer based in United States. It appears in 17 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 May 2024 as NAI.
1
registered plants
1 with an FDA FEI number
17
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 17 May 2024 NAI US FDA
- 13 January 2023 VAI US FDA
- 30 March 2022 VAI US FDA
- 5 November 2020 OAI US FDA
- 8 November 2018 VAI US FDA
- 23 February 2018 VAI US FDA
- 8 August 2017 VAI US FDA
- 14 February 2017 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Somerset, United States | 3006271438 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 17 | 1 |
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Open risk flags
- 20 active litigation matters are on record.
- The most recent inspection outcome was NAI, on 17 May 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates