Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-17.
At a glance
Inspections
9
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Feb 2023 – 17 Feb 2023 | Human Drugs | WL | View 483 → |
| 27 Jun 2022 – 1 Jul 2022 | Human Drugs | 483 | On file |
| 13 May 2019 – 17 May 2019 | Human Drugs | Clean | |
| 2 Apr 2018 – 13 Apr 2018 | Human Drugs | 483 | On file |
| 19 Jun 2017 – 23 Jun 2017 | Human Drugs | 483 | View 483 → |
| 23 Jan 2017 – 27 Jan 2017 | Human Drugs | Clean | |
| 27 Jul 2015 – 7 Aug 2015 | Human Drugs | 483 | View 483 → |
| 25 Feb 2013 – 1 Mar 2013 | Human Drugs | 483 | View 483 → |
| 2 Nov 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Feb 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Saleem A Akhtar, Jose E Melendez
17 Feb 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Saleem A Akhtar, Jose E Melendez
17 Feb 2023
21 CFR 211.194(a)
Complete test data included in records
Cited by Saleem A Akhtar, Jose E Melendez
17 Feb 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Saleem A Akhtar, Jose E Melendez
Investigators
FDA investigators tied to this site in the record.
Saleem A Akhtar1 insp.
Jose E Melendez1 insp.
Dipesh K Shah1 insp.
Sangeeta M Khurana1 insp.
Abby L Mozeke-Baker1 insp.
Patric C Klotzbuecher1 insp.
Paul C Mouris1 insp.
Doan T Nguyen1 insp.
Laurimer Kuilan-Torres1 insp.
Ademola O Daramola1 insp.
Nebil A Oumer1 insp.
Peter E Baker1 insp.
William A Warnick1 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 | 6x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | 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