Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-13.
At a glance
Inspections
8
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Nov 2024 – 13 Nov 2024 | Human Drugs | 483 | On file |
| 15 Jul 2019 – 19 Jul 2019 | Human Drugs | 483 | On file |
| 29 Mar 2017 – 5 Apr 2017 | Human Drugs | Clean | |
| 21 Jul 2014 – 25 Jul 2014 | Human Drugs | 483 | On file |
| 28 Jun 2012 | Not recorded | 483 | On file |
| 9 Apr 2009 | Not recorded | 483 | View 483 → |
| 20 Oct 2005 | Not recorded | Clean | |
| 31 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Apr 2009
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Luis A Dasta, Vlada Matusovsky, Julianne C Mccullough
9 Apr 2009
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Luis A Dasta, Vlada Matusovsky, Julianne C Mccullough
9 Apr 2009
21 CFR 211.180(b)
Record maintenance 1 year (except exempt OTC)
Cited by Luis A Dasta, Vlada Matusovsky, Julianne C Mccullough
9 Apr 2009
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Luis A Dasta, Vlada Matusovsky, Julianne C Mccullough
9 Apr 2009
21 CFR 211.192
Quality control unit review of records
Cited by Luis A Dasta, Vlada Matusovsky, Julianne C Mccullough
Investigators
FDA investigators tied to this site in the record.
Guerlain Ulysse1 insp.
Kellia N Hicks1 insp.
Christopher S Keating1 insp.
Ralph H Vocque1 insp.
Jose M Cayuela1 insp.
Steven D Kehoe1 insp.
S. L Brown1 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 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 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 211.67(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cipla Limited's 5 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