Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-08.
At a glance
Inspections
9
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Apr 2024 – 8 May 2024 | Human Drugs | 483 | On file |
| 11 Mar 2019 – 20 Mar 2019 | Human Drugs | 483 | On file |
| 26 Nov 2018 – 30 Nov 2018 | Human Drugs | 483 | View 483 → |
| 28 Nov 2016 – 9 Dec 2016 | Human Drugs | 483 | On file |
| 19 May 2014 – 23 May 2014 | Human Drugs | Clean | |
| 1 Dec 2011 | Not recorded | 483 | View 483 → |
| 26 Mar 2009 | Not recorded | 483 | View 483 → |
| 14 Nov 2002 | Not recorded | Clean | |
| 24 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Dec 2011
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles
Investigators
FDA investigators tied to this site in the record.
Santos E Camara1 insp.
Haitao Li1 insp.
Angela E Glenn1 insp.
Cheryl A Clausen1 insp.
Rozelle G Smith1 insp.
Saleem A Akhtar1 insp.
Jogy George1 insp.
Helen Verdel1 insp.
Michael A Charles1 insp.
Luis A Dasta1 insp.
Vlada Matusovsky1 insp.
Julianne C Mccullough1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 Cipla 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