Glenmark Pharmaceuticals Inc.
Form 483 issued July 26, 2019 · Monroe, North Carolina
- Inspection
- Jul 22 – Jul 26, 2019
- Observations
- 1
- Pages
- 2
- FEI number
- 3011585599
In short: On July 26, 2019, FDA issued a Form 483 with 1 observation to Glenmark Pharmaceuticals Inc. in Monroe, North Carolina (FEI 3011585599) after an inspection that ran Jul 22 – Jul 26, 2019. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Questions about this 483
What did FDA find at Glenmark Pharmaceuticals Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Glenmark Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jul 22 – Jul 26, 2019, and the Form 483 is dated July 26, 2019.
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.