Intas Pharmaceuticals Limited
Form 483 issued February 28, 2020 · Ahmedabad, India
- Inspection
- Feb 24 – Feb 28, 2020
- Investigator
- Jennifer L. Huntington
- Observations
- 1
- Pages
- 2
- FEI number
- 3004011473
In short: On February 28, 2020, FDA issued a Form 483 with 1 observation to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3004011473) after an inspection that ran Feb 24 – Feb 28, 2020. The investigator was Jennifer L. Huntington. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmIntas Pharmaceuticals Limited history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuticals Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuticals Limited?
Jennifer L. Huntington is named on this Form 483, for the inspection of Feb 24 – Feb 28, 2020. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran Feb 24 – Feb 28, 2020, and the Form 483 is dated February 28, 2020.
How do I get the full Form 483 for Intas 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.