Glenmark Pharmaceuticals Ltd
Form 483 issued May 24, 2018 · Pithampur, India
- Inspection
- May 24, 2018
- Investigators
- Arsen Karapetyan· Pratik S. Upadhyay
- Observations
- 1
- Pages
- 7
- FEI number
- 3008565058
In short: On May 24, 2018, FDA issued a Form 483 with 1 observation to Glenmark Pharmaceuticals Ltd in Pithampur, India (FEI 3008565058) after an inspection that ran May 24, 2018. The investigators were Arsen Karapetyan and Pratik S. Upadhyay. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmGlenmark Pharmaceuticals Ltd history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Glenmark Pharmaceuticals Ltd?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Ltd?
Arsen Karapetyan and Pratik S. Upadhyay are named on this Form 483, for the inspection of May 24, 2018. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Ltd inspected by FDA?
The inspection ran May 24, 2018, and the Form 483 is dated May 24, 2018.
How do I get the full Form 483 for Glenmark Pharmaceuticals Ltd?
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.