Site records / Uttarakhand / FEI 3005890633

Intas Pharmaceuticals LimitedDehradun, Uttarakhand

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

Inspections posted
1
Last inspection
Sep 2025 · OAI
Warning letters to this FEI
1
Import alerts at this address
0 of 2 under the name
US border refusals, 2 years
0
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

1 FDA inspection of this FEI, by end date; 1 with a posted classification.

  1. 16 Sep 2025OAI · Official Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 30 Mar 2026Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
  2. 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
  3. 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.

  1. 14 Nov 2023Import alert 66-40 · Published address is another site of this firm SourcePublished address: Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA
  2. 1 Jun 2023Import alert 66-40 · Published address is another site of this firm SourcePublished address: Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA

Form 483s released by FDA

  1. 17 Sep 2025Form 483 · 5 pages Source

Other registered sites of Intas (unlisted)

Registration

FEI
3005890633
DUNS
858328710
Registered as
Intas Pharmaceuticals Limited
Registrant
Intas Pharmaceuticals Limited
Address
Camp Road, Selaqui, Dehradun, Uttarakhand 248011, 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.

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