Glenmark Pharmaceuticals Limited
FDA inspection history across 3 sites, 2017 to 2022
- 3
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2017: one Form 483; 2019: one close-out letter and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s and one close-out letter, at Solan, India; Mumbai, India and Baddi, India.
- 2022One Form 483, at Baddi, India.
- 2022The longest 483 on file: 6 observations over 7 pages at Baddi, India.
Cited most
Across all Glenmark Pharmaceuticals Limited observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.198Complaint files2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Glenmark Pharmaceuticals 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
Baddi, India
Two Form 483s · 2019 to 2022 · 6 observations
Latest: Form 483, Jun 22, 2022 →Mumbai, India
One close-out letter · 2019
Latest: Close-out, Oct 3, 2019 →Solan, India
One Form 483 · 2017 · 1 observation
Latest: Form 483, Nov 11, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-22 | 483 Form 483 | Baddi, India | 6 | $99 |
| 2019-10-03 | Close-out Close-out letter | Mumbai, India | — | $99 |
| 2019-04-20 | 483 Form 483 | Baddi, India | — | $99 |
| 2017-11-11 | 483 Form 483 | Solan, India | 1 | $99 |
Investigators on these documents
Dipesh K. Shah (1)Joel D. Hustedt (1)Jogy George (1)Marcellinus D. Dordunoo (1)Rita K. Kabaso (1)
FEI number 3005757050 · most recent document Jun 22, 2022
About Glenmark Pharmaceuticals Limited
How many FDA Form 483s has Glenmark Pharmaceuticals Limited received?
FDA Intel has 3 Form 483s on file for Glenmark Pharmaceuticals Limited; the most recent is dated Jun 22, 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 Jun 22, 2022, for the site in Baddi, 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 211.192 (Production record review), 4 times; 21 CFR 211.198 (Complaint files), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.