Sun Pharmaceutical Medicare Limited
FDA inspection history across 2 sites, 2019 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Halol, India.
- 2023–25Three Form 483s, at Halol Panchmahal, India and Halol, India.
- 2024The longest 483 on file: 3 observations over 4 pages at Halol Panchmahal, India.
Cited most
Across all Sun Pharmaceutical Medicare Limited observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.113Control of microbiological contamination2
The complete Sun Pharmaceutical Medicare Limited file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Halol, India
Two Form 483s · 2019 to 2025 · 2 observations
Latest: Form 483, Sep 19, 2025 →Halol Panchmahal, India
Two Form 483s · 2023 to 2024 · 4 observations
Latest: Form 483, Feb 27, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-19 | 483 Form 483 | Halol, India | 1 | $99 |
| 2024-02-27 | 483 Form 483 | Halol Panchmahal, India | 3 | $99 |
| 2023-07-13 | 483 Form 483 | Halol Panchmahal, India | 1 | $99 |
| 2019-02-05 | 483 Form 483 | Halol, India | 1 | $99 |
Investigators on these documents
Claudia M. Perez-Kasmarski (1)Eileen A. Liu (1)Junho Pak (1)Tamil Arasu (1)
FEI number 3002957541 · most recent document Sep 19, 2025
About Sun Pharmaceutical Medicare Limited
How many FDA Form 483s has Sun Pharmaceutical Medicare Limited received?
FDA Intel has 4 Form 483s on file for Sun Pharmaceutical Medicare Limited; the most recent is dated Sep 19, 2025.
When was Sun Pharmaceutical Medicare Limited last inspected by FDA?
The most recent FDA inspection document on file for Sun Pharmaceutical Medicare Limited is a Form 483 dated Sep 19, 2025, for the site in Halol, India.
What did FDA cite at Sun Pharmaceutical Medicare Limited?
The regulations cited most in the observations on file for Sun Pharmaceutical Medicare Limited are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.