Overview
- 16 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-07.
At a glance
Inspections
16
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 May 2023 – 7 Jun 2023 | Human Drugs | 483 | View 483 → |
| 16 Dec 2019 – 20 Dec 2019 | Human Drugs | Clean | |
| 12 Apr 2019 – 18 Apr 2019 | Human Drugs | Clean | |
| 22 Jan 2019 – 30 Jan 2019 | Human Drugs | 483 | View 483 → |
| 9 Jul 2018 – 10 Jul 2018 | Human Drugs | Clean | |
| 3 Jan 2018 – 18 Jan 2018 | Human Drugs | 483 | View 483 → |
| 2 May 2017 – 24 May 2017 | Human Drugs | 483 | View 483 → |
| 5 May 2014 – 16 May 2014 | Human Drugs | 483 | View 483 → |
| 24 Jun 2013 – 3 Jul 2013 | Human Drugs | 483 | View 483 → |
| 10 Jan 2013 | Not recorded | 483 | On file |
| 3 Jul 2012 | Not recorded | Clean | |
| 10 Mar 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Jun 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Vivin George, Amatul H Marium, Miral B Patel
7 Jun 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Vivin George, Amatul H Marium, Miral B Patel
7 Jun 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Vivin George, Amatul H Marium, Miral B Patel
7 Jun 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Vivin George, Amatul H Marium, Miral B Patel
7 Jun 2023
21 CFR 211.63
Equipment Design, Size and Location
Cited by Vivin George, Amatul H Marium, Miral B Patel
Investigators
FDA investigators tied to this site in the record.
Robert C Horan3 insp.
Robert C Steyert2 insp.
Uduak M Inokon2 insp.
Alice S Tsao2 insp.
Vivin George1 insp.
Amatul H Marium1 insp.
Miral B Patel1 insp.
Yvesna C Blaise1 insp.
Iram R Hassan1 insp.
Patric C Klotzbuecher1 insp.
Ruo H Xu1 insp.
Karen L Kosar1 insp.
Tara K Carmody1 insp.
Peter S Diak1 insp.
Jay T Wong1 insp.
Rachael A Moliver1 insp.
Tara K Normandin1 insp.
Neil J Bonzagni1 insp.
James A Liubicich1 insp.
Douglas G Ng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amneal Pharmaceuticals of New York, LLC's 8 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