Site records / Gujarat / FEI 3003157498
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
- 11
- Last inspection
- Jul 2024 · NAI
- Warning letters to this FEI
- 1
- Import alerts at this address
- 1 of 2 under the name
- US border refusals, 2 years
- 34
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
11 FDA inspections of this FEI, by end date; 11 with a posted classification.
- 12 Jul 2024NAI · No Action IndicatedBioresearch Monitoring · no citations posted
- 2 Aug 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 14 citations posted
- 14 Dec 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 8 Jun 2018VAI · Voluntary Action IndicatedPre-Approval Eval. of Animal Drugs and Food Additives · 2 citations posted
- 17 Feb 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 17 Jun 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 7 Apr 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 21 Jun 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 19 May 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 10 Oct 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 13 Nov 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 21 Nov 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
- 28 Jul 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.
- 14 Nov 2023Import alert 66-40 · Published address is this site SourcePublished address: Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA
- 1 Jun 2023Import alert 66-40 · Published address cannot be tied to one site SourcePublished address: Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA
Form 483s released by FDA
- 12 May 2023Form 483 · 29 pages Source
Other registered sites of Intas (unlisted)
- Intas Pharmaceuticals LimitedAhmedabad, Gujarat
- Intas Pharmaceuticals LimitedDehradun, Uttarakhand
- Intas Pharmaceuticals LimitedBharuch, Gujarat
Registration
- FEI
- 3003157498
- DUNS
- 725927649
- Registered as
- Intas Pharmaceuticals Limited
- Registrant
- Intas Pharmaceuticals Limited
- Address
- Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway , Taluka -Sanand, Matoda, Ahmedabad, Gujarat 382210, 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.