Sun Pharmaceutical Industries Ltd.
FDA inspection history across 2 sites, 2013 to 2025
- 8
- Form 483s
- 2
- Warning letters
- 1
- EIR
Every document, by year
- Form 483
- Warning letter
- EIR
2013: one inspection report; 2015: one warning letter; 2016: one Form 483; 2018: two Form 483s; 2019: two Form 483s; 2022: one Form 483; 2023: one warning letter; 2025: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–19Five Form 483s, one inspection report and one warning letter, at Halol, India.
- 2022–25Three Form 483s and one warning letter, at Halol, India and Mumbai, India.
- 2022The longest 483 on file: 10 observations over 23 pages at Halol, India.
Cited most
Across all Sun Pharmaceutical Industries observations on file
- 21 CFR 211.113Control of microbiological contamination9
- 21 CFR 211.160General requirements6
- 21 CFR 211.192Production record review4
- 21 CFR 211.42(c)(10)Design and construction features4
- 21 CFR 211.100Written procedures; deviations3
The complete Sun Pharmaceutical Industries file.
All 11 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Halol, India
Eight Form 483s and one inspection report · 2013 to 2025 · 42 observations
Latest: Form 483, Jun 13, 2025 →Mumbai, India
One warning letter · 2023
Latest: Warning letter, Oct 16, 2023 →
Also: one document not tied to a site.
Documents
11 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-13 | 483 Form 483 | Halol, India | 8 | $99 |
| 2025-06-02 | 483 Form 483 | Halol, India | 8 | $99 |
| 2023-10-16 | Warning letter Warning letter | Mumbai, India | — | $99 |
| 2022-05-09 | 483 Form 483 | Halol, India | 10 | $99 |
| 2019-12-13 | 483 Form 483 | Halol, India | 8 | $99 |
| 2019-06-11 | 483 Form 483 | Halol, India | 4 | $99 |
| 2018-08-31 | 483 Form 483 | Halol, India | 2 | $99 |
| 2018-02-23 | 483 Form 483 | Halol, India | 1 | $99 |
| 2016-12-01 | 483 Form 483 | Halol, India | 1 | $99 |
| 2015-12-17 | Warning letter Warning letter | — | — | $99 |
| 2013-07-09 | EIR EIR | Halol, India | — | $550 |
Investigators on these documents
Lisa L. Flores (2)Pratik S. Upadhyay (2)Justin A. Boyd (2)Kellia N. Hicks (2)Jose E. Melendez (1)Jose M. Cayuela (1)Kejun Cheng (1)Monica C. Burgos Garcia (1)Parul M. Patel (1)Patric C. Klotzbuecher (1)Rebecca E. Dombrowski (1)Saleem A. Akhtar (1)
FEI number 3002809586 · most recent document Jun 13, 2025
About Sun Pharmaceutical Industries Ltd.
How many FDA Form 483s has Sun Pharmaceutical Industries Ltd. received?
FDA Intel has 8 Form 483s on file for Sun Pharmaceutical Industries Ltd.; the most recent is dated Jun 13, 2025.
When was Sun Pharmaceutical Industries Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Sun Pharmaceutical Industries Ltd. is a Form 483 dated Jun 13, 2025, for the site in Halol, India.
What did FDA cite at Sun Pharmaceutical Industries Ltd.?
The regulations cited most in the observations on file for Sun Pharmaceutical Industries Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 9 times; 21 CFR 211.160 (General requirements), 6 times; 21 CFR 211.192 (Production record review), 4 times.
Has Sun Pharmaceutical Industries Ltd. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Sun Pharmaceutical Industries Ltd.; the most recent is dated Oct 16, 2023.