Sun Pharmaceuticals Industries, Inc
FDA inspection history across 2 sites, 2016 to 2022
- 3
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2020: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at S.A.S. Nagar, Mohali, India.
- 2016The longest 483 on file: 7 observations over 4 pages at S.A.S. Nagar, Mohali, India.
- 2020–22Two Form 483s, at Mohali, India.
Cited most
Across all Sun Pharmaceuticals Industries observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Sun Pharmaceuticals Industries file.
All 3 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
Mohali, India
Two Form 483s · 2020 to 2022 · 7 observations
Latest: Form 483, Aug 12, 2022 →S.A.S. Nagar, Mohali, India
One Form 483 · 2016 · 7 observations
Latest: Form 483, Nov 16, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-08-12 | 483 Form 483 | Mohali, India | 6 | $99 |
| 2020-02-07 | 483 Form 483 | Mohali, India | 1 | $99 |
| 2016-11-16 | 483 Form 483 | S.A.S. Nagar, Mohali, India | 7 | $99 |
Investigators on these documents
Daniel J. Roberts (1)Felix Maldonado (1)Jeffrey P. Raimondi (1)Jonah S. Ufferfilge (1)Justin A. Boyd (1)Philip F. Istafanos (1)Steven D. Kehoe (1)Teresa I. Navas (1)
FEI number 3002807979 · most recent document Aug 12, 2022
About Sun Pharmaceuticals Industries, Inc
How many FDA Form 483s has Sun Pharmaceuticals Industries, Inc received?
FDA Intel has 3 Form 483s on file for Sun Pharmaceuticals Industries, Inc; the most recent is dated Aug 12, 2022.
When was Sun Pharmaceuticals Industries, Inc last inspected by FDA?
The most recent FDA inspection document on file for Sun Pharmaceuticals Industries, Inc is a Form 483 dated Aug 12, 2022, for the site in Mohali, India.
What did FDA cite at Sun Pharmaceuticals Industries, Inc?
The regulations cited most in the observations on file for Sun Pharmaceuticals Industries, Inc are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.160(a) (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times.