Glenmark Pharmaceuticals Limited
Form 483 issued June 22, 2022 · Baddi, India
- Inspection
- Jun 13 – Jun 22, 2022
- Investigators
- Joel D. Hustedt· Marcellinus D. Dordunoo
- Observations
- 6
- Pages
- 7
- FEI number
- 3005757050
In short: On June 22, 2022, FDA issued a Form 483 with 6 observations to Glenmark Pharmaceuticals Limited in Baddi, Himachal Pradesh (FEI 3005757050) after an inspection that ran Jun 13 – Jun 22, 2022. The investigators were Joel D. Hustedt and Marcellinus D. Dordunoo. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
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…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
An Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
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 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Limited?
Joel D. Hustedt and Marcellinus D. Dordunoo are named on this Form 483, for the inspection of Jun 13 – Jun 22, 2022. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Limited inspected by FDA?
The inspection ran Jun 13 – Jun 22, 2022, and the Form 483 is dated June 22, 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.