Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-17.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2023 – 17 Nov 2023 | Human Drugs | 483 | On file |
| 17 Oct 2019 – 25 Oct 2019 | Human Drugs | 483 | View 483 → |
| 8 Mar 2018 – 15 Mar 2018 | Human Drugs | 483 | View 483 → |
| 30 May 2016 – 8 Jun 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Mar 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anastasia M Shields, Carrie A Hughes
15 Mar 2018
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Anastasia M Shields, Carrie A Hughes
15 Mar 2018
21 CFR 211.192
Written record of investigation incomplete
Cited by Anastasia M Shields, Carrie A Hughes
15 Mar 2018
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Anastasia M Shields, Carrie A Hughes
Investigators
FDA investigators tied to this site in the record.
Rajiv R Srivastava1 insp.
Eileen A Liu1 insp.
Felix Maldonado1 insp.
Anastasia M Shields1 insp.
Carrie A Hughes1 insp.
Lucila B Nwatu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amneal Oncology Private Limited's 4 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