Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-10.
At a glance
Inspections
10
Form 483s
7
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jul 2025 – 10 Jul 2025 | Medical Devices & Rad Health | Clean | |
| 15 Aug 2024 – 23 Aug 2024 | Biologics | 483 | View 483 → |
| 17 Feb 2020 – 25 Feb 2020 | Human Drugs | 483 | View 483 → |
| 4 Mar 2019 – 12 Mar 2019 | Biologics | 483 | View 483 → |
| 26 Feb 2019 – 28 Feb 2019 | Human Drugs | Clean | |
| 8 May 2018 – 11 May 2018 | Medical Devices & Rad Health | Clean | |
| 16 May 2017 – 19 May 2017 | Biologics | 483 | On file |
| 29 Feb 2016 – 3 Mar 2016 | Human Drugs | 483 | View 483 → |
| 23 Sep 2014 – 29 Sep 2014 | Biologics | 483 | On file |
| 2 Dec 2013 – 6 Dec 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Feb 2020
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Christopher R Czajka
Investigators
FDA investigators tied to this site in the record.
Rosanna M Goodrich1 insp.
Gene D Arcy1 insp.
Peng Zhou1 insp.
Christopher R Czajka1 insp.
Susan M Jackson1 insp.
MRA McCulloughJ1 insp.
Marissa S Steinhagen1 insp.
Richard H Coats1 insp.
Joan Johnson1 insp.
Francis A Guidry1 insp.
Christine Harman1 insp.
Susan S Yu1 insp.
Michael R Goga1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NOVA LABORATORIES LIMITED's 7 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