Cipla Limited
FDA inspection history across 3 sites, 2018 to 2023
- 5
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2022: two Form 483s; 2023: two Form 483s and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Pithampur, India.
- 2022–23Four Form 483s and one warning letter, at Pithampur Dhar, India; Indore SEZ, Pithampur, India and Pithampur, India.
- 2023The longest 483 on file: 8 observations over 23 pages at Pithampur Dhar, India.
Cited most
Across all Cipla Limited observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.180General requirements2
- 21 CFR 211.192Production record review2
The complete Cipla Limited file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Pithampur Dhar, India
Two Form 483s · 2022 to 2023 · 10 observations
Latest: Form 483, Feb 17, 2023 →Pithampur, India
Two Form 483s · 2018 to 2023 · 9 observations
Latest: Form 483, Feb 6, 2023 →Indore SEZ, Pithampur, India
One Form 483 · 2022 · 2 observations
Latest: Form 483, Jul 1, 2022 →
Also: one document not tied to a site.
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-17 | Warning letter Warning letter | — | — | $99 |
| 2023-02-17 | 483 Form 483 | Pithampur Dhar, India | 8 | $99 |
| 2023-02-06 | 483 Form 483 | Pithampur, India | 8 | $99 |
| 2022-07-01 | 483 Form 483 | Pithampur Dhar, India | 2 | $99 |
| 2022-07-01 | 483 Form 483 | Indore SEZ, Pithampur, India | 2 | $99 |
| 2018-04-13 | 483 Form 483 | Pithampur, India | 1 | $99 |
Investigators on these documents
Dipesh K. Shah (2)Jose E. Melendez (2)Saleem A. Akhtar (2)Patric C. Klotzbuecher (1)
FEI number 3008581988 · most recent document Nov 17, 2023
About Cipla Limited
How many FDA Form 483s has Cipla Limited received?
FDA Intel has 5 Form 483s on file for Cipla Limited; the most recent is dated Feb 17, 2023.
When was Cipla Limited last inspected by FDA?
The most recent FDA inspection document on file for Cipla Limited is a Form 483 dated Feb 17, 2023, for the site in Pithampur Dhar, India.
What did FDA cite at Cipla Limited?
The regulations cited most in the observations on file for Cipla Limited are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.166 (Stability testing), 2 times.
Has Cipla Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Cipla Limited; the most recent is dated Nov 17, 2023.