Intas Pharmaceuticals Limited
Form 483 issued July 31, 2017 · Ahmedabad, India
- Inspection
- Jul 24 – Jul 31, 2017
- Observations
- 1
- Pages
- 1
- FEI number
- 3003157498
In short: On July 31, 2017, FDA issued a Form 483 with 1 observation to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3003157498) after an inspection that ran Jul 24 – Jul 31, 2017. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Sampling procedures are deficient regarding sampling components from the…
This inspection in context
Questions about this 483
What did FDA find at Intas Pharmaceuticals Limited?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran Jul 24 – Jul 31, 2017, and the Form 483 is dated July 31, 2017.
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.