Glenmark Pharmaceuticals Limited
Form 483 issued May 20, 2022 · Colvale, India
- Inspection
- May 12 – May 20, 2022
- Investigators
- Jose M. Cayuela· Justin A. Boyd
- Observations
- 5
- Pages
- 14
- FEI number
- 3004672766
In short: On May 20, 2022, FDA issued a Form 483 with 5 observations to Glenmark Pharmaceuticals Limited in Colvale, Goa (FEI 3004672766) after an inspection that ran May 12 – May 20, 2022. The investigators were Jose M. Cayuela and Justin A. Boyd. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Glenmark Pharmaceuticals Limited?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Limited?
Jose M. Cayuela and Justin A. Boyd are named on this Form 483, for the inspection of May 12 – May 20, 2022. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Limited inspected by FDA?
The inspection ran May 12 – May 20, 2022, and the Form 483 is dated May 20, 2022.
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.