Glenmark Pharmaceuticals Limited
Form 483 issued April 20, 2019 · Baddi, India
- Inspection
- Apr 15 – Apr 20, 2019
- Investigator
- Rita K. Kabaso
- Observations
- 4
- Pages
- 11
- FEI number
- 3005757050
In short: On April 20, 2019, FDA issued a Form 483 with 4 observations to Glenmark Pharmaceuticals Limited in Baddi, Himachal Pradesh (FEI 3005757050) after an inspection that ran Apr 15 – Apr 20, 2019. The investigator was Rita K. Kabaso. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×) · 211.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into “grittiness” of Mometasone Furoate Cream USP 0.1% were not thorough and extended to other…
- 02
Shipping temperature excursions associated with market complaints were not thoroughly investigated. The established shipping temperatures for…
- 03
Stability samples are not tested in a timely manner representative of the stability…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
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 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. 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?
Rita K. Kabaso is named on this Form 483, for the inspection of Apr 15 – Apr 20, 2019. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Limited inspected by FDA?
The inspection ran Apr 15 – Apr 20, 2019, and the Form 483 is dated April 20, 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.