Overview
- 14 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-08.
At a glance
Inspections
14
Form 483s
6
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Jan 2024 – 8 Feb 2024 | Human Drugs | Clean | |
| 15 Aug 2023 – 21 Aug 2023 | Medical Devices & Rad Health | Clean | |
| 14 Nov 2022 – 18 Nov 2022 | Human Drugs | 483 | On file |
| 9 Jul 2021 – 20 Jul 2021 | Human Drugs | Clean | |
| 5 Feb 2019 – 21 Feb 2019 | Human Drugs | 483 | View 483 → |
| 12 Jul 2017 – 27 Jul 2017 | Human Drugs | 483 | On file |
| 7 Oct 2015 – 16 Oct 2015 | Human Drugs | 483 | On file |
| 8 Oct 2013 – 17 Oct 2013 | Human Drugs | Clean | |
| 11 Jul 2013 – 19 Jul 2013 | Human Drugs | 483 | On file |
| 15 Nov 2011 | Not recorded | Clean | |
| 16 Dec 2010 | Not recorded | Clean | |
| 27 Jul 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Dec 2008
21 CFR 211.28(b)
Habits of good sanitation & health
Cited by Justine Tomasso, Douglas C Kovacs
17 Dec 2008
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Justine Tomasso, Douglas C Kovacs
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy3 insp.
James R Birkenstamm2 insp.
Douglas C Kovacs2 insp.
Rose L Jean-Mary1 insp.
Jacqueline S Warner1 insp.
Jogy George1 insp.
Pushpa S Jayasekara1 insp.
Karishma G Gopaul1 insp.
Helen Verdel1 insp.
Jay B Shah1 insp.
Adetutu M Gidado1 insp.
Michael Serrano1 insp.
Addam S Reynolds1 insp.
Justine Tomasso1 insp.
Daniel J Grabicki1 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 | 2x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(1) | 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 Amneal Pharmaceuticals LLC's 6 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