Overview
- 20 FDA inspections are on record.
- 16 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
20
Form 483s
16
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 17 Apr 2026 | Human Drugs | 483 | View 483 → |
| 29 Sep 2025 – 10 Oct 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jan 2025 – 31 Jan 2025 | Human Drugs | Clean | |
| 7 May 2024 – 17 May 2024 | Human Drugs | 483 | On file |
| 4 Jan 2023 – 13 Jan 2023 | Human Drugs | 483 | View 483 → |
| 7 Mar 2022 – 30 Mar 2022 | Human Drugs | 483 | On file |
| 10 Sep 2020 – 5 Nov 2020 | Human Drugs | WL | On file |
| 3 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | View 483 → |
| 31 Oct 2018 – 8 Nov 2018 | Human Drugs | 483 | View 483 → |
| 12 Feb 2018 – 23 Feb 2018 | Human Drugs | 483 | View 483 → |
| 30 Oct 2017 – 3 Nov 2017 | Human Drugs | Clean | |
| 19 Jun 2017 – 8 Aug 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Apr 2026
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Daniel T Lee, Anthony J Donato
17 Apr 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Daniel T Lee, Anthony J Donato
10 Oct 2025
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by William R Chang, Jaro P Perera
13 Jan 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by David A Oluwo, Janet A Rajan, Karishma G Gopaul
Investigators
FDA investigators tied to this site in the record.
Nancy M Espinal3 insp.
Suchan Kim2 insp.
Adetutu M Gidado2 insp.
Ko U Min2 insp.
Lata C Mathew2 insp.
Paul L Bellamy2 insp.
Nicholas A Violand2 insp.
Russell J Glapion2 insp.
Daniel T Lee1 insp.
Anthony J Donato1 insp.
William R Chang1 insp.
Jaro P Perera1 insp.
Annet R Rajan1 insp.
Jenny Sung1 insp.
Daniel L Zheng1 insp.
David A Oluwo1 insp.
Janet A Rajan1 insp.
Karishma G Gopaul1 insp.
Sandra A Boyd1 insp.
Saleem A Akhtar1 insp.
Unnee Ranjan1 insp.
Jogy George1 insp.
Shirley S Wen1 insp.
Sena G Dissmeyer1 insp.
Himanshu Gupta1 insp.
Srinivas Chennamaneni1 insp.
Yvesna C Blaise1 insp.
Nancy F Scheraga1 insp.
Junho Pak1 insp.
Barbara J Wilimczyk-Macri1 insp.
Lauren L Vajo1 insp.
Douglas C Kovacs1 insp.
Karen E Dorazio1 insp.
Jose A Cruz Gonzalez1 insp.
Annemarie Bodnar1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novel Laboratories, Inc. d.b.a Lupin Somerset's 16 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat