Intas Pharmaceuti cal s Li mi ted
Form 483 issued September 17, 2025 · Dehradun, India
- Inspection
- Sep 8 – Sep 17, 2025
- Investigators
- Saleem A. Akhtar· Tamil Arasu
- Observations
- 3
- Pages
- 5
- FEI number
- 3005890633
In short: On September 17, 2025, FDA issued a Form 483 with 3 observations to Intas Pharmaceuti cal s Li mi ted in Dehradun, Utah (FEI 3005890633) after an inspection that ran Sep 8 – Sep 17, 2025. The investigators were Saleem A. Akhtar and Tamil Arasu. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
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 whether or not the batch has…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Batch production and control records do not include complete information relating to the production and…
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 firmIntas Pharmaceuti cal s Li mi ted 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 Intas Pharmaceuti cal s Li mi ted?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuti cal s Li mi ted?
Saleem A. Akhtar and Tamil Arasu are named on this Form 483, for the inspection of Sep 8 – Sep 17, 2025. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuti cal s Li mi ted inspected by FDA?
The inspection ran Sep 8 – Sep 17, 2025, and the Form 483 is dated September 17, 2025.
How do I get the full Form 483 for Intas Pharmaceuti cal s Li mi ted?
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.