Glenmark Pharmaceuticals Limited
Form 483 issued September 27, 2019 · Colvale-Bardez, India
- Inspection
- Sep 23 – Sep 27, 2019
- Investigator
- Michele L. Glendenning
- Observations
- 2
- Pages
- 2
- FEI number
- 3004672766
In short: On September 27, 2019, FDA issued a Form 483 with 2 observations to Glenmark Pharmaceuticals Limited in Colvale-Bardez, GA (FEI 3004672766) after an inspection that ran Sep 23 – Sep 27, 2019. The investigator was Michele L. Glendenning. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Michele L. Glendenning
18 documents · 2018–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Illinois.
The firmGlenmark Pharmaceuticals Limited history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Glenmark Pharmaceuticals Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Limited?
Michele L. Glendenning is named on this Form 483, for the inspection of Sep 23 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Limited inspected by FDA?
The inspection ran Sep 23 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for Glenmark Pharmaceuticals Limited?
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.