Glenmark Pharmaceuticals Limited
Form 483 issued November 11, 2017 · Solan, India
- Inspection
- Nov 6 – Nov 11, 2017
- Investigators
- Dipesh K. Shah· Jogy George
- Observations
- 1
- Pages
- 11
- FEI number
- 3005757050
In short: On November 11, 2017, FDA issued a Form 483 with 1 observation to Glenmark Pharmaceuticals Limited in Solan, India (FEI 3005757050) after an inspection that ran Nov 6 – Nov 11, 2017. The investigators were Dipesh K. Shah and Jogy George. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
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 4 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 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Limited?
Dipesh K. Shah and Jogy George are named on this Form 483, for the inspection of Nov 6 – Nov 11, 2017. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Limited inspected by FDA?
The inspection ran Nov 6 – Nov 11, 2017, and the Form 483 is dated November 11, 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.