Sun Pharma Canada Inc.
FDA inspection history across 2 sites, 2008 to 2022
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2008: one warning letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One warning letter, at Hawthorne, New York.
- 2022One Form 483, at Brampton, Canada.
Cited most
Across all Sun Pharma Canada observations on file
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete Sun Pharma Canada file.
All 2 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
Brampton, Canada
One Form 483 · 2022 · 2 observations
Latest: Form 483, Sep 16, 2022 →Hawthorne, New York
One warning letter · 2008
Latest: Warning letter, Jul 31, 2008 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-16 | 483 Form 483 | Brampton, Canada | 2 | $99 |
| 2008-07-31 | Warning letter Warning letter | Hawthorne, New York | — | $99 |
Investigators on these documents
FEI number 3002808384 · most recent document Sep 16, 2022
About Sun Pharma Canada Inc.
How many FDA Form 483s has Sun Pharma Canada Inc. received?
FDA Intel has 1 Form 483 on file for Sun Pharma Canada Inc.; the most recent is dated Sep 16, 2022.
When was Sun Pharma Canada Inc. last inspected by FDA?
The most recent FDA inspection document on file for Sun Pharma Canada Inc. is a Form 483 dated Sep 16, 2022, for the site in Brampton, Canada.
What did FDA cite at Sun Pharma Canada Inc.?
The regulations cited most in the observations on file for Sun Pharma Canada Inc. are 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time.
Has Sun Pharma Canada Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sun Pharma Canada Inc.; the most recent is dated Jul 31, 2008.