Glenmark Pharmaceuticals Inc.
Form 483 issued June 17, 2025 · Monroe, North Carolina
- Inspection
- Jun 9 – Jun 17, 2025
- Investigators
- Damaris Y. Hernandez· Homero W. Aguilar· Luis P. Torres
- Observations
- 5
- Pages
- 9
- FEI number
- 3011585599
In short: On June 17, 2025, FDA issued a Form 483 with 5 observations to Glenmark Pharmaceuticals Inc. in Monroe, North Carolina (FEI 3011585599) after an inspection that ran Jun 9 – Jun 17, 2025. The investigators were Damaris Y. Hernandez, Homero W. Aguilar, Luis P. Torres and Saundrea A. Munroe. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education…
- 03
The quality control unit lacks authority to fully investigate…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmGlenmark Pharmaceuticals Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Glenmark Pharmaceuticals Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Inc.?
Damaris Y. Hernandez, Homero W. Aguilar, Luis P. Torres and Saundrea A. Munroe are named on this Form 483, for the inspection of Jun 9 – Jun 17, 2025. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jun 9 – Jun 17, 2025, and the Form 483 is dated June 17, 2025.
How do I get the full Form 483 for Glenmark Pharmaceuticals Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.