Intas Pharmaceuticals Limited
Form 483 issued December 14, 2018 · Ahmedabad, India
- Inspection
- Dec 10 – Dec 14, 2018
- Investigator
- Vilmary Negron Rodriguez
- Observations
- 1
- Pages
- 1
- FEI number
- 3003157498
In short: On December 14, 2018, FDA issued a Form 483 with 1 observation to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3003157498) after an inspection that ran Dec 10 – Dec 14, 2018. The investigator was Vilmary Negron Rodriguez. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
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…
This inspection in context
Vilmary Negron Rodriguez
6 documents · 2015–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmIntas Pharmaceuticals Limited history
All 7 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 Pharmaceuticals Limited?
FDA listed 1 observation on this Form 483, mostly about production. 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 Pharmaceuticals Limited?
Vilmary Negron Rodriguez is named on this Form 483, for the inspection of Dec 10 – Dec 14, 2018. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran Dec 10 – Dec 14, 2018, and the Form 483 is dated December 14, 2018.
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.