Intas Pharmaceuticals Limited
Form 483 issued May 12, 2023 · Ahmedabad, India
- Inspection
- May 1 – May 12, 2023
- Investigators
- Arsen Karapetyan· Justin A. Boyd· Rita K. Kabaso
- Observations
- 16
- Pages
- 29
- FEI number
- 3003157498
In short: On May 12, 2023, FDA issued a Form 483 with 16 observations to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3003157498) after an inspection that ran May 1 – May 12, 2023. The investigators were Arsen Karapetyan, Justin A. Boyd and Rita K. Kabaso. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 11 of 16 observations.
Most cited: 21 CFR 211.42 (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include complete information relating to the production and…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuticals Limited?
FDA listed 16 observations on this Form 483, mostly about facilities & equipment, production 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?
Arsen Karapetyan, Justin A. Boyd and Rita K. Kabaso are named on this Form 483, for the inspection of May 1 – May 12, 2023. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran May 1 – May 12, 2023, and the Form 483 is dated May 12, 2023.
How do I get the full Form 483 for Intas Pharmaceuticals Limited?
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