Company
United StatesGlenmark Pharmaceuticals Inc USA, Monroe, NC – FDA Inspections
Inspection records and compliance data for Glenmark Pharmaceuticals Inc USA in Monroe, North Carolina. 4 FDA inspections on record (1 OAI), 3 Form 483s, last inspected June 17, 2025.
Company Profile
This profile covers Glenmark Pharmaceuticals Inc USA based in Monroe, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected May 18, 2018. Last inspected June 17, 2025.
Most cited issue areas
- Procedures for sterile drug products3 inspections
- Authority lacking to review records, investigate errors2 inspections
- Training , Education , Experience overall2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 17, 2025 | Not classified | Human Drugs · Drug Quality Assurance | 1267093 |
| May 19, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1169876 |
| July 26, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1097806 |
| May 18, 2018 | VAI | Human Drugs · Generic Drug Evaluation | 1052635 |
FDA documents
Form 483s (3)
- Form 483s · June 17, 2025
- Form 483s · May 19, 2022
- Form 483s · July 26, 2019
People (5)
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FRESENIUS MEDICAL CARE ANDINA S A S
Company Information
Name
Glenmark Pharmaceuticals Inc USA
FEI Number
3011585599
Address
4147 Goldmine Rd, Monroe, North Carolina 28110, United States
Country
United States
ID: 83c18d68-8e9d-454a-a365-3fe29c7d3e31