Intas Pharmaceuti cal s Li mi ted
Form 483 issued January 20, 2023 · Selaqui, India
- Inspection
- Jan 10 – Jan 20, 2023
- Investigators
- Arsen Karapetyan· Teresa I. Navas
- Observations
- 7
- Pages
- 7
- FEI number
- 3005890633
In short: On January 20, 2023, FDA issued a Form 483 with 7 observations to Intas Pharmaceuti cal s Li mi ted in Selaqui, Uttarakhand (FEI 3005890633) after an inspection that ran Jan 10 – Jan 20, 2023. The investigators were Arsen Karapetyan and Teresa I. Navas. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 03
Written records of investigations into the failure of a batch or any of its components to…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) 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 211.113
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 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuti cal s Li mi ted?
Arsen Karapetyan and Teresa I. Navas are named on this Form 483, for the inspection of Jan 10 – Jan 20, 2023. 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 Jan 10 – Jan 20, 2023, and the Form 483 is dated January 20, 2023.
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.