Glenmark Pharmaceuticals Limited
Form 483 issued March 31, 2017 · Colvale-Bardez, India
- Inspection
- Mar 20 – Mar 31, 2017
- Investigators
- Dennis Cantellops· Lidia Lugo
- Observations
- 1
- Pages
- 5
- FEI number
- 3004672766
In short: On March 31, 2017, FDA issued a Form 483 with 1 observation to Glenmark Pharmaceuticals Limited in Colvale-Bardez, India (FEI 3004672766) after an inspection that ran Mar 20 – Mar 31, 2017. The investigators were Dennis Cantellops and Lidia Lugo. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Production System) Control procedures are not established which monitor the output and validate the performance of…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Glenmark Pharmaceuticals Limited?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Limited?
Dennis Cantellops and Lidia Lugo are named on this Form 483, for the inspection of Mar 20 – Mar 31, 2017. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Limited inspected by FDA?
The inspection ran Mar 20 – Mar 31, 2017, and the Form 483 is dated March 31, 2017.
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.