Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-30.
At a glance
Inspections
12
Form 483s
5
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Apr 2026 – 30 Apr 2026 | Human Drugs | Clean | |
| 24 Mar 2025 – 28 Mar 2025 | Human Drugs | Clean | |
| 17 Nov 2023 – 21 Nov 2023 | Human Drugs | Clean | |
| 24 Jan 2022 – 10 Feb 2022 | Human Drugs | 483 | View 483 → |
| 15 Oct 2018 – 19 Oct 2018 | Human Drugs | Clean | |
| 19 Mar 2018 – 6 Apr 2018 | Human Drugs | 483 | View 483 → |
| 6 Mar 2017 – 20 Mar 2017 | Human Drugs | Clean | |
| 25 Jul 2016 – 5 Aug 2016 | Human Drugs | 483 | On file |
| 11 Feb 2016 – 19 Feb 2016 | Human Drugs | Clean | |
| 9 Oct 2014 – 23 Oct 2014 | Human Drugs | 483 | On file |
| 8 Jul 2013 – 19 Jul 2013 | Human Drugs | 483 | On file |
| 18 Jun 2013 – 26 Jun 2013 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2022
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Jonathan G Matrisciano, Daniel L Zheng
10 Feb 2022
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Jonathan G Matrisciano, Daniel L Zheng
10 Feb 2022
21 CFR 211.63
Equipment Design, Size and Location
Cited by Jonathan G Matrisciano, Daniel L Zheng
10 Feb 2022
21 CFR 211.63
Equipment Design, Size and Location
Cited by Jonathan G Matrisciano, Daniel L Zheng
6 Apr 2018
21 CFR 211.192
Written record of investigation incomplete
Cited by Yvesna C Blaise, Amy M Cramer
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy3 insp.
Alisha B Patel1 insp.
Sarmistha Sanyal1 insp.
Mayar M Mussa1 insp.
Anthony J Donato1 insp.
Stephenie M Ortiz1 insp.
Suchan Kim1 insp.
Jenny Sung1 insp.
Jonathan G Matrisciano1 insp.
Daniel L Zheng1 insp.
Srinivas Chennamaneni1 insp.
Yvesna C Blaise1 insp.
Amy M Cramer1 insp.
Nicola M Fenty-Stewart1 insp.
Frederick Razzaghi1 insp.
Michael Serrano1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amneal Pharmaceuticals, LLC's 5 Form 483s
Source PDFs 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