Overview
- 16 FDA inspections are on record.
- 14 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
16
Form 483s
14
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Apr 2026 – 17 Apr 2026 | Human Drugs | 483 | View 483 → |
| 10 Jun 2024 – 21 Jun 2024 | Human Drugs | 483 | View 483 → |
| 16 Aug 2022 – 26 Aug 2022 | Human Drugs | 483 | View 483 → |
| 16 Sep 2019 – 27 Sep 2019 | Human Drugs | WL | View 483 → |
| 21 Jan 2019 – 28 Jan 2019 | Human Drugs | 483 | View 483 → |
| 24 Sep 2018 – 28 Sep 2018 | Human Drugs | 483 | On file |
| 22 Jan 2018 – 25 Jan 2018 | Human Drugs | 483 | View 483 → |
| 5 Jun 2017 – 16 Jun 2017 | Human Drugs | 483 | On file |
| 22 Aug 2016 – 30 Aug 2016 | Human Drugs | 483 | View 483 → |
| 8 Apr 2015 – 17 Apr 2015 | Human Drugs | 483 | On file |
| 16 Sep 2013 – 19 Sep 2013 | Human Drugs | Clean | |
| 20 May 2013 – 30 May 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Apr 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jeffrey P Raimondi, Anastasia M Shields, Karishma G Gopaul
17 Apr 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey P Raimondi, Anastasia M Shields, Karishma G Gopaul
21 Jun 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tamil Arasu, Eileen A Liu, Joseph A Piechocki
21 Jun 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Tamil Arasu, Eileen A Liu, Joseph A Piechocki
Investigators
FDA investigators tied to this site in the record.
Thomas J Arista2 insp.
Cheryl A Clausen2 insp.
Jeffrey P Raimondi1 insp.
Anastasia M Shields1 insp.
Karishma G Gopaul1 insp.
Tamil Arasu1 insp.
Eileen A Liu1 insp.
Joseph A Piechocki1 insp.
Justin A Boyd1 insp.
Teresa I Navas1 insp.
Jonah S Ufferfilge1 insp.
Rajiv R Srivastava1 insp.
June P Page1 insp.
Angela E Glenn1 insp.
Nicole E Knowlton1 insp.
Rebecca E Dombrowski1 insp.
Pei-I Chu1 insp.
Michele Perry-Williams1 insp.
Stephen D Brown1 insp.
Nicholas A Violand1 insp.
Jose A Lopez Rubet1 insp.
Sharon K Thoma1 insp.
Scott B Laufenberg1 insp.
Ramon E Martinez1 insp.
Michael A Charles1 insp.
Ralph H Vocque1 insp.
Charisse K Green1 insp.
Sixto M Mercado Rios1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 13x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 11x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | 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 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cipla Limited's 14 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