Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-19.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2024 – 19 Jun 2024 | Human Drugs | 483 | View 483 → |
| 13 Dec 2022 – 23 Dec 2022 | Human Drugs | 483 | On file |
| 12 Feb 2020 – 18 Feb 2020 | Human Drugs | Clean | |
| 27 Mar 2019 – 5 Apr 2019 | Human Drugs | 483 | View 483 → |
| 16 Apr 2018 – 24 Apr 2018 | Human Drugs | 483 | On file |
| 13 Mar 2017 – 21 Mar 2017 | Human Drugs | 483 | On file |
| 17 Aug 2015 – 25 Aug 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jun 2024
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Bijoy Panicker, Jigar R Patel
19 Jun 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Bijoy Panicker, Jigar R Patel
19 Jun 2024
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Bijoy Panicker, Jigar R Patel
Investigators
FDA investigators tied to this site in the record.
Bijoy Panicker1 insp.
Jigar R Patel1 insp.
Thomas J Arista1 insp.
Edmund F Mrak1 insp.
Matthew B Casale1 insp.
Niketa Patel1 insp.
Marie B Buen-Bigornia1 insp.
Samantha J Bradley1 insp.
Linda F Murphy1 insp.
Xiomara Copeland1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amneal Pharmaceuticals Private Limited'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