Intas Pharmaceuticals Limited
Form 483 issued June 8, 2018 · Ahmedabad, India
- Inspection
- May 31 – Jun 8, 2018
- Investigator
- Matthew B. Casale
- Observations
- 2
- Pages
- 4
- FEI number
- 3003157498
In short: On June 8, 2018, FDA issued a Form 483 with 2 observations to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3003157498) after an inspection that ran May 31 – Jun 8, 2018. The investigator was Matthew B. Casale. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
(b) (A) processing areas are deficient regarding the system…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 211.42(c)(10)(iv)
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 quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuticals Limited?
Matthew B. Casale is named on this Form 483, for the inspection of May 31 – Jun 8, 2018. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran May 31 – Jun 8, 2018, and the Form 483 is dated June 8, 2018.
How do I get the full Form 483 for Intas Pharmaceuticals Limited?
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