Glenmark Pharmaceuticals Limited
FDA inspection history across 3 sites, 2017 to 2022
- 4
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2017: one Form 483; 2019: two Form 483s; 2022: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Three Form 483s, at Colvale-Bardez, India.
- 2022One warning letter and one Form 483, at Mumbai, India and Colvale, India.
- 2022The longest 483 on file: 5 observations over 14 pages at Colvale, India.
Cited most
Across all Glenmark Pharmaceuticals Limited observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(a)Testing and release for distribution1
The complete Glenmark Pharmaceuticals Limited file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Colvale-Bardez, India
Three Form 483s · 2017 to 2019 · 3 observations
Latest: Form 483, Sep 27, 2019 →Colvale, India
One Form 483 and one close-out letter · 2022 · 5 observations
Latest: Form 483, May 20, 2022 →Mumbai, India
One warning letter · 2022
Latest: Warning letter, Nov 22, 2022 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-22 | Warning letter Warning letter | Mumbai, India | — | $99 |
| 2022-05-20 | 483 Form 483 | Colvale, India | 5 | $99 |
| 2019-09-27 | 483 Form 483 | Colvale-Bardez, India | 2 | $99 |
| 2019-03-15 | 483 Form 483 | Colvale-Bardez, India | — | $99 |
| 2017-03-31 | 483 Form 483 | Colvale-Bardez, India | 1 | $99 |
| Undated | Close-out Close-out letter | Colvale, India | — | $99 |
Investigators on these documents
Dennis Cantellops (1)Jose M. Cayuela (1)Justin A. Boyd (1)Lidia Lugo (1)Michele L. Glendenning (1)Sandra A. Hughes (1)
FEI number 3004672766 · most recent document Nov 22, 2022
About Glenmark Pharmaceuticals Limited
How many FDA Form 483s has Glenmark Pharmaceuticals Limited received?
FDA Intel has 4 Form 483s on file for Glenmark Pharmaceuticals Limited; the most recent is dated May 20, 2022.
When was Glenmark Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Glenmark Pharmaceuticals Limited is a Form 483 dated May 20, 2022, for the site in Colvale, India.
What did FDA cite at Glenmark Pharmaceuticals Limited?
The regulations cited most in the observations on file for Glenmark Pharmaceuticals Limited are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has Glenmark Pharmaceuticals Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Glenmark Pharmaceuticals Limited; the most recent is dated Nov 22, 2022.