Glenmark Pharmaceuticals Limited
Form 483 issued March 15, 2019 · Colvale-Bardez, India
- Inspection
- Mar 7 – Mar 15, 2019
- Investigator
- Sandra A. Hughes
- Observations
- 5
- Pages
- 5
- FEI number
- 3004672766
In short: On March 15, 2019, FDA issued a Form 483 with 5 observations to Glenmark Pharmaceuticals Limited in Colvale-Bardez, GA (FEI 3004672766) after an inspection that ran Mar 7 – Mar 15, 2019. The investigator was Sandra A. Hughes. Most observations concern laboratory controls and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
This inspection in context
Sandra A. Hughes
23 documents · 2009–2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
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(a)
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 laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Limited?
Sandra A. Hughes is named on this Form 483, for the inspection of Mar 7 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Limited inspected by FDA?
The inspection ran Mar 7 – Mar 15, 2019, and the Form 483 is dated March 15, 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.