Novel Laboratories, Inc.
FDA inspection history across 2 sites, 2018 to 2026
- 5
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2018: one Form 483; 2020: one Form 483; 2021: one warning letter; 2022: one Form 483; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–23Four Form 483s and one warning letter, at Somerset, New Jersey and Mumbai, India.
- 2020The longest 483 on file: 13 observations over 39 pages at Somerset, New Jersey.
- 2026One Form 483, at Somerset, New Jersey.
Cited most
Across all Novel Laboratories observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.160General requirements3
- 21 CFR 211.165Testing and release for distribution3
The complete Novel Laboratories file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Somerset, New Jersey
Five Form 483s · 2018 to 2026 · 37 observations
Latest: Form 483, Apr 17, 2026 →Mumbai, India
One warning letter and one close-out letter · 2021
Latest: Warning letter, Jun 11, 2021 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-17 | 483 Form 483 | Somerset, New Jersey | 3 | $99 |
| 2023-01-13 | 483 Form 483 | Somerset, New Jersey | 2 | $99 |
| 2022-03-30 | 483 Form 483 | Somerset, New Jersey | 13 | $99 |
| 2021-06-11 | Warning letter Warning letter | Mumbai, India | — | $99 |
| 2020-11-05 | 483 Form 483 | Somerset, New Jersey | 13 | $99 |
| 2018-12-21 | 483 Form 483 | Somerset, New Jersey | 6 | $99 |
| Undated | Close-out Close-out letter | Mumbai, India | — | $99 |
Investigators on these documents
Lata Mathew (2)Ko U. Min (2)Daniel T. Lee (1)Jogy George (1)Karishma G. Gopaul (1)Saleem A. Akhtar (1)Sandra A. Boyd (1)Adetutu Gidado (1)Unnee Ranjan (1)Anthony Donato (1)
FEI number 3006271438 · most recent document Apr 17, 2026
About Novel Laboratories, Inc.
How many FDA Form 483s has Novel Laboratories, Inc. received?
FDA Intel has 5 Form 483s on file for Novel Laboratories, Inc.; the most recent is dated Apr 17, 2026.
When was Novel Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Novel Laboratories, Inc. is a Form 483 dated Apr 17, 2026, for the site in Somerset, New Jersey.
What did FDA cite at Novel Laboratories, Inc.?
The regulations cited most in the observations on file for Novel Laboratories, Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times.
Has Novel Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Novel Laboratories, Inc.; the most recent is dated Jun 11, 2021.