Site records / Gujarat / FEI 3004011473

Intas Pharmaceuticals LimitedAhmedabad, Gujarat

FDA-registered drug establishment in Ahmedabad, Gujarat: analysis, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted: 7
Last inspection: Dec 2022 · OAI
Warning letters to this FEI: 1
Import alerts at this address: 1 of 2 under the name
US border refusals, 2 years: 9

The site dossier

This site, graded.
Every fact sourced.

A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
Warning-letter violations, numbered and labelled
Import-alert history rebuilt from the archive, each listing checked against this address
Border refusals by product, and the company's other sites, each graded
A hash of every source read, so the PDF can be checked against the record

On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.

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Inspections

7 FDA inspections of this FEI, by end date; 7 with a posted classification.

2 Dec 2022OAI · Official Action IndicatedDrug Quality Assurance · 11 citations posted
28 Feb 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
28 May 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
19 Oct 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · 4 citations posted
19 Dec 2014NAI · No Action IndicatedDrug Quality Assurance · no citations posted
27 Jun 2013NAI · No Action IndicatedDrug Quality Assurance · no citations posted
21 Oct 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

28 Jul 2023Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
30 Mar 2026Warning letter to Intas Pharmaceuticals Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
21 Nov 2023Warning letter to Intas Pharmaceuticals Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI

Import alerts in force

Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.

1 Jun 2023Import alert 66-40 · Published address is this site SourcePublished address: Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA
14 Nov 2023Import alert 66-40 · Published address cannot be tied to one site SourcePublished address: Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA

Form 483s released by FDA

2 Dec 2022Form 483 · 36 pages Source

Other registered sites of Intas (unlisted)

Intas Pharmaceuticals LimitedAhmedabad, Gujarat
Intas Pharmaceuticals LimitedDehradun, Uttarakhand
Intas Pharmaceuticals LimitedBharuch, Gujarat

Registration

FEI: 3004011473
DUNS: 915837971
Registered as: Intas Pharmaceuticals Limited
Registrant: Intas Pharmaceuticals Limited
Address: Plot No. 5 to 14, Pharmez, Near Village Matoda, Sarkhej-Bavla Highway, No. 8-A, Taluka Sanand, Ahmedabad, Gujarat 382213, India (IND)
Operations: ANALYSIS, MANUFACTURE, PACK
Registration expires: 31 Dec 2026

Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.