Glenmark Pharmaceuticals Inc.
FDA inspection history in Monroe, North Carolina, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Monroe, North Carolina.
- 2025One Form 483, at Monroe, North Carolina.
- 2025The longest 483 on file: 5 observations over 9 pages at Monroe, North Carolina.
Cited most
Across all Glenmark Pharmaceuticals observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.22(a)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Glenmark Pharmaceuticals 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
Monroe, North Carolina
Two Form 483s · 2019 to 2025 · 6 observations
Latest: Form 483, Jun 17, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-17 | 483 Form 483 | Monroe, North Carolina | 5 | $99 |
| 2019-07-26 | 483 Form 483 | Monroe, North Carolina | 1 | $99 |
Investigators on these documents
Damaris Y. Hernandez (1)Homero W. Aguilar (1)Luis P. Torres (1)Saundrea A. Munroe (1)
FEI number 3011585599 · most recent document Jun 17, 2025
About Glenmark Pharmaceuticals Inc.
How many FDA Form 483s has Glenmark Pharmaceuticals Inc. received?
FDA Intel has 2 Form 483s on file for Glenmark Pharmaceuticals Inc.; the most recent is dated Jun 17, 2025.
When was Glenmark Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Glenmark Pharmaceuticals Inc. is a Form 483 dated Jun 17, 2025, for the site in Monroe, North Carolina.
What did FDA cite at Glenmark Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Glenmark Pharmaceuticals Inc. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 1 time; 21 CFR 211.25(a) (Personnel qualifications), 1 time.