Drug establishmentActive, Registered FY2026FDA warning letter on file

Intas Pharmaceuticals Limited

Intas Pharmaceuticals Limited is an FDA-registered drug establishment (FEI 3004011473) located in . The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Mar 30, 2026
CGMP/Finished Pharmaceuticals/Adulterated

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number
3004011473
Address
Plot No. 5 to 14, ,
Establishment type
Drug establishment
Products / operations
ANALYSIS; MANUFACTURE; PACK
Registration status
Active, Registered FY2026

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Inspection history

Inspections on file
None on file
Form 483 observations
None on file

FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.

Questions

Is Intas Pharmaceuticals Limited registered with the FDA?

Yes. Intas Pharmaceuticals Limited is an FDA-registered drug establishment (FEI 3004011473) in . Its current registration status is Active, Registered FY2026.

Has Intas Pharmaceuticals Limited received an FDA warning letter?

Yes. FDA issued a warning letter to Intas Pharmaceuticals Limited; the most recent is dated Mar 30, 2026 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Intas Pharmaceuticals Limited do?

Intas Pharmaceuticals Limited's FDA-registered operations are: ANALYSIS; MANUFACTURE; PACK.

Related facilities

Source: FDA public data · status as of 2026-06-01

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