Glenmark Pharmaceuticals Ltd
Form 483 issued February 14, 2025 · Pithampur, India
- Inspection
- Feb 3 – Feb 14, 2025
- Investigators
- Saleem A. Akhtar· Tamil Arasu
- Observations
- 5
- Pages
- 14
- FEI number
- 3008565058
In short: On February 14, 2025, FDA issued a Form 483 with 5 observations to Glenmark Pharmaceuticals Ltd in Pithampur, Madhya Pradesh (FEI 3008565058) after an inspection that ran Feb 3 – Feb 14, 2025. The investigators were Saleem A. Akhtar and Tamil Arasu. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) 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 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Glenmark Pharmaceuticals Ltd?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Glenmark Pharmaceuticals Ltd?
Saleem A. Akhtar and Tamil Arasu are named on this Form 483, for the inspection of Feb 3 – Feb 14, 2025. Each investigator has a profile showing what they cite most.
When was Glenmark Pharmaceuticals Ltd inspected by FDA?
The inspection ran Feb 3 – Feb 14, 2025, and the Form 483 is dated February 14, 2025.
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.