Cipla Limited
FDA inspection history across 5 sites, 2016 to 2026
- 8
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2016: one Form 483; 2018: two Form 483s; 2019: two Form 483s; 2020: one close-out letter; 2022: one Form 483; 2024: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–26Eight Form 483s and one close-out letter, at Salcette, India; Verna, India; Vasco Da Gama, India and two other sites.
- 2019The longest 483 on file: 10 observations over 38 pages at Vasco Da Gama, India.
Cited most
Across all Cipla Limited observations on file
- 21 CFR 211.42(a)Design and construction features6
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review5
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.67(a)Equipment cleaning and maintenance3
The complete Cipla Limited file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Salcette, India
Four Form 483s · 2016 to 2026 · 10 observations
Latest: Form 483, Apr 17, 2026 →Verna, India
Two Form 483s · 2018 to 2024 · 8 observations
Latest: Form 483, Jun 21, 2024 →Verna, Salcette, Goa, India
One Form 483 · 2022 · 6 observations
Latest: Form 483, Aug 26, 2022 →Mumbai, India
One close-out letter · 2020
Latest: Close-out, Feb 25, 2020 →Vasco Da Gama, India
One Form 483 · 2019 · 10 observations
Latest: Form 483, Sep 27, 2019 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-17 | 483 Form 483 | Salcette, India | 2 | $99 |
| 2024-06-21 | 483 Form 483 | Verna, India | 6 | $99 |
| 2022-08-26 | 483 Form 483 | Verna, Salcette, Goa, India | 6 | $99 |
| 2020-02-25 | Close-out Close-out letter | Mumbai, India | — | $99 |
| 2019-09-27 | 483 Form 483 | Vasco Da Gama, India | 10 | $99 |
| 2019-01-28 | 483 Form 483 | Salcette, India | 6 | $99 |
| 2018-09-28 | 483 Form 483 | Verna, India | 2 | $99 |
| 2018-01-25 | 483 Form 483 | Salcette, India | 1 | $99 |
| 2016-08-30 | 483 Form 483 | Salcette, India | 1 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Angela E. Glenn (1)Cheryl Clausen (1)Eileen A. Liu (1)Jeffrey P. Raimondi (1)Jonah S. Ufferfilge (1)Joseph A. Piechocki (1)June P. Page (1)Justin A. Boyd (1)Karishma G. Gopaul (1)Nicholas Violand (1)Nicole E. Knowlton (1)
FEI number 3004081307 · most recent document Apr 17, 2026
About Cipla Limited
How many FDA Form 483s has Cipla Limited received?
FDA Intel has 8 Form 483s on file for Cipla Limited; the most recent is dated Apr 17, 2026.
When was Cipla Limited last inspected by FDA?
The most recent FDA inspection document on file for Cipla Limited is a Form 483 dated Apr 17, 2026, for the site in Salcette, India.
What did FDA cite at Cipla Limited?
The regulations cited most in the observations on file for Cipla Limited are 21 CFR 211.42(a) (Design and construction features), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 5 times.