Glenmark Pharmaceuticals Ltd
FDA inspection history in Pithampur, India, 2018 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Pithampur, India.
- 2025One warning letter and one Form 483, at Pithampur, India.
- 2025The longest 483 on file: 5 observations over 14 pages at Pithampur, India.
Cited most
Across all Glenmark Pharmaceuticals observations on file
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(c)Responsibilities of quality control unit1
- 21 CFR 211.42(c)(5)Design and construction features1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Glenmark Pharmaceuticals 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
Pithampur, India
Two Form 483s · 2018 to 2025 · 6 observations
Latest: Form 483, Feb 14, 2025 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-11 | Warning letter Warning letter | — | — | $99 |
| 2025-02-14 | 483 Form 483 | Pithampur, India | 5 | $99 |
| 2018-05-24 | 483 Form 483 | Pithampur, India | 1 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Pratik S. Upadhyay (1)Saleem A. Akhtar (1)Tamil Arasu (1)
FEI number 3008565058 · most recent document Jul 11, 2025
About Glenmark Pharmaceuticals Ltd
How many FDA Form 483s has Glenmark Pharmaceuticals Ltd received?
FDA Intel has 2 Form 483s on file for Glenmark Pharmaceuticals Ltd; the most recent is dated Feb 14, 2025.
When was Glenmark Pharmaceuticals Ltd last inspected by FDA?
The most recent FDA inspection document on file for Glenmark Pharmaceuticals Ltd is a Form 483 dated Feb 14, 2025, for the site in Pithampur, India.
What did FDA cite at Glenmark Pharmaceuticals Ltd?
The regulations cited most in the observations on file for Glenmark Pharmaceuticals Ltd are 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22(c) (Responsibilities of quality control unit), 1 time.
Has Glenmark Pharmaceuticals Ltd received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Glenmark Pharmaceuticals Ltd; the most recent is dated Jul 11, 2025.