Intas Pharmaceuticals Limited
Form 483 issued February 2, 2022 · Ahmedabad, India
- Inspection
- Feb 2, 2022
- Investigators
- Jose E. Melendez· Justin A. Boyd· Pratik S. Upadhyay
- Observations
- 11
- Pages
- 36
- FEI number
- 3004011473
In short: On February 2, 2022, FDA issued a Form 483 with 11 observations to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3004011473) after an inspection that ran Feb 2, 2022. The investigators were Jose E. Melendez, Justin A. Boyd and Pratik S. Upadhyay. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
Established test procedures and laboratory control…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmIntas Pharmaceuticals Limited history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuticals Limited?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuticals Limited?
Jose E. Melendez, Justin A. Boyd and Pratik S. Upadhyay are named on this Form 483, for the inspection of Feb 2, 2022. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran Feb 2, 2022, and the Form 483 is dated February 2, 2022.
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.