Emcure Pharmaceuticals Limited
FDA inspection history across 2 sites, 2016 to 2019
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2016: one warning letter; 2019: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter.
- 2019One close-out letter and one Form 483, at Maharashtra, India and Hinjwadi, India.
Cited most
Across all Emcure Pharmaceuticals Limited observations on file
- 21 CFR 211.192Production record review1
The complete Emcure Pharmaceuticals Limited 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
Maharashtra, India
One close-out letter · 2019
Latest: Close-out, Aug 2, 2019 →Hinjwadi, India
One Form 483 · 2019 · 1 observation
Latest: Form 483, Feb 20, 2019 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-02 | Close-out Close-out letter | Maharashtra, India | — | $99 |
| 2019-02-20 | 483 Form 483 | Hinjwadi, India | 1 | $99 |
| 2016-03-03 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3005151215 · most recent document Aug 2, 2019
About Emcure Pharmaceuticals Limited
How many FDA Form 483s has Emcure Pharmaceuticals Limited received?
FDA Intel has 1 Form 483 on file for Emcure Pharmaceuticals Limited; the most recent is dated Feb 20, 2019.
When was Emcure Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Emcure Pharmaceuticals Limited is a Form 483 dated Feb 20, 2019, for the site in Hinjwadi, India.
What did FDA cite at Emcure Pharmaceuticals Limited?
The regulations cited most in the observations on file for Emcure Pharmaceuticals Limited are 21 CFR 211.192 (Production record review), 1 time.
Has Emcure Pharmaceuticals Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Emcure Pharmaceuticals Limited; the most recent is dated Mar 3, 2016.