Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-08.
At a glance
Inspections
8
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 May 2025 – 8 May 2025 | Human Drugs | Clean | |
| 13 May 2024 – 17 May 2024 | Human Drugs | 483 | View 483 → |
| 3 Feb 2020 – 7 Feb 2020 | Human Drugs | Clean | |
| 3 Apr 2018 – 18 Apr 2018 | Human Drugs | 483 | View 483 → |
| 23 Aug 2017 – 31 Aug 2017 | Human Drugs | Clean | |
| 22 Feb 2017 – 23 Feb 2017 | Human Drugs | Clean | |
| 24 Mar 2016 – 28 Mar 2016 | Human Drugs | Clean | |
| 29 Jan 2015 – 4 Feb 2015 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2024
21 CFR 211.68(b)
Computer control of master formula records
Cited by Rose L Jean-Mary, Miral B Patel
Investigators
FDA investigators tied to this site in the record.
Niketa Patel2 insp.
Janet A Rajan1 insp.
Michael O Idowu1 insp.
Divek R Jumani1 insp.
Rose L Jean-Mary1 insp.
Miral B Patel1 insp.
Monika Borkowska1 insp.
Nancy F Scheraga1 insp.
Yvesna C Blaise1 insp.
Helen Verdel1 insp.
Frederick Razzaghi1 insp.
Paul L Bellamy1 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 | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amneal Complex Products Research LLC's 2 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