Intas Pharmaceuticals Limited
Form 483 issued August 2, 2019 · Ahmedabad, India
- Inspection
- Jul 22 – Aug 2, 2019
- Investigator
- Yasamin Ameri
- Observations
- 14
- Pages
- 26
- FEI number
- 3003157498
In short: On August 2, 2019, FDA issued a Form 483 with 14 observations to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3003157498) after an inspection that ran Jul 22 – Aug 2, 2019. The investigator was Yasamin Ameri. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 10 of 14 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
The suitability of all testing methods is not verified under…
- 03
Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuticals Limited?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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?
Yasamin Ameri is named on this Form 483, for the inspection of Jul 22 – Aug 2, 2019. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran Jul 22 – Aug 2, 2019, and the Form 483 is dated August 2, 2019.
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.