Intas Pharmaceuticals Limited
Form 483 issued February 17, 2017 · Ahmedabad, India
- Inspection
- Feb 13 – Feb 17, 2017
- Investigator
- Unnee Ranjan
- Observations
- 2
- Pages
- 2
- FEI number
- 3003157498
In short: On February 17, 2017, FDA issued a Form 483 with 2 observations to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3003157498) after an inspection that ran Feb 13 – Feb 17, 2017. The investigator was Unnee Ranjan. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.142 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established. Equipment and utensils are not cleaned and stored to prevent contamination…
- 02
Materials are not stored under conditions and for a period that have no adverse…
This inspection in context
Unnee Ranjan
30 documents · 2015–2026
Cites 211.67 (equipment cleaning and maintenance) 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuticals Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuticals Limited?
Unnee Ranjan is named on this Form 483, for the inspection of Feb 13 – Feb 17, 2017. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran Feb 13 – Feb 17, 2017, and the Form 483 is dated February 17, 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.