FDA Intel

Intas Pharmaceuticals Limited

Form 483 issued December 2, 2022 · Ahmedabad, India

Inspection
Nov 22 – Dec 2, 2022
Investigators
Jose E. Melendez· Justin A. Boyd· Pratik S. Upadhyay
Observations
11
Pages
36
FEI number
3004011473

In short: On December 2, 2022, FDA issued a Form 483 with 11 observations to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3004011473) after an inspection that ran Nov 22 – Dec 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 211.192 (production record review).

At a glance

Laboratory controls and quality system account for 7 of 11 observations.

Laboratory controls4
Quality system3
Production2
Facilities & equipment2

Most cited: 21 CFR 211.192 (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.194(a)

    Observation 1: scanned text, readable in the full document.

  2. 02
    21 CFR 211.160(a)

    Established test procedures and laboratory control mechanisms are not followed. There is no procedure describing the…

  3. 03
    21 CFR 11

    The responsibilities and procedures applicable to the quality control unit…

  4. 04
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…

7 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

Intas Pharmaceuticals Limited history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other 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 211.192 (production record review). 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 Nov 22 – Dec 2, 2022. Each investigator has a profile showing what they cite most.

When was Intas Pharmaceuticals Limited inspected by FDA?

The inspection ran Nov 22 – Dec 2, 2022, and the Form 483 is dated December 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.

$99Get it free