Glenmark Pharmaceuticals Limited
Form 483 issued July 1, 2022 · Chhatrapati Sambhajinagar (previously known as Aurangabad), India
- Inspection
- Jun 27 – Jul 1, 2022
- Investigator
- Rajiv R. Srivastava
- Observations
- 1
- Pages
- 2
- FEI number
- 3009915929
In short: On July 1, 2022, FDA issued a Form 483 with 1 observation to Glenmark Pharmaceuticals Limited in Chhatrapati Sambhajinagar (previously known as Aurangabad), Maharashtra (FEI 3009915929) after an inspection that ran Jun 27 – Jul 1, 2022. The investigator was Rajiv R. Srivastava. 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 observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
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
The site's inspection history, in date order.
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?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Jun 27 – Jul 1, 2022. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Limited inspected by FDA?
The inspection ran Jun 27 – Jul 1, 2022, and the Form 483 is dated July 1, 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.