Sun Pharmaceuticals Industries Ltd.
FDA inspection history across 2 sites, 2017 to 2024
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2017: one Form 483; 2019: one Form 483; 2023: two Form 483s; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Dadra, India.
- 2019The longest 483 on file: 11 observations over 10 pages at Dadra, India.
- 2023–24Two Form 483s and one warning letter, at Dadra, India and Mumbai, India.
Cited most
Across all Sun Pharmaceuticals Industries observations on file
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.170Reserve samples3
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.194Laboratory records2
The complete Sun Pharmaceuticals Industries file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Dadra, India
Four Form 483s · 2017 to 2023 · 34 observations
Latest: Form 483, Dec 15, 2023 →Mumbai, India
One warning letter · 2024
Latest: Warning letter, Jun 18, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-18 | Warning letter Warning letter | Mumbai, India | — | $99 |
| 2023-12-15 | 483 Form 483 | Dadra, India | 6 | $99 |
| 2023-12-15 | 483 Form 483 | Dadra, India | 6 | $99 |
| 2019-03-29 | 483 Form 483 | Dadra, India | 11 | $99 |
| 2017-04-13 | 483 Form 483 | Dadra, India | 11 | $99 |
Investigators on these documents
Pratik S. Upadhyay (2)Angela E. Glenn (1)Cheryl Clausen (1)Daniel J. Roberts (1)Sony Mathews (1)
FEI number 3004561553 · most recent document Jun 18, 2024
About Sun Pharmaceuticals Industries Ltd.
How many FDA Form 483s has Sun Pharmaceuticals Industries Ltd. received?
FDA Intel has 4 Form 483s on file for Sun Pharmaceuticals Industries Ltd.; the most recent is dated Dec 15, 2023.
When was Sun Pharmaceuticals Industries Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Sun Pharmaceuticals Industries Ltd. is a Form 483 dated Dec 15, 2023, for the site in Dadra, India.
What did FDA cite at Sun Pharmaceuticals Industries Ltd.?
The regulations cited most in the observations on file for Sun Pharmaceuticals Industries Ltd. are 21 CFR 211.22 (Responsibilities of quality control unit), 5 times; 21 CFR 211.170 (Reserve samples), 3 times; 21 CFR 211.192 (Production record review), 3 times.
Has Sun Pharmaceuticals Industries Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sun Pharmaceuticals Industries Ltd.; the most recent is dated Jun 18, 2024.