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Intas Pharmaceuticals Limited — FDA Warning Letter

Issued to Intas Pharmaceuticals Limited. Serious post-market compliance violation.

Issued

March 30, 2026

Product

CGMP/Finished Pharmaceuticals/Adulterated

Company

Intas Pharmaceuticals Limited

Review center

CDER

Stage

Final Decision

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Why did Intas Pharmaceuticals Limited receive an FDA warning letter?

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Source facts

FDA issued a warning letter to Intas Pharmaceuticals Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Quality systems and CAPA, Manufacturing and CGMP controls, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

Key details in this letter

  • 1Subject: CGMP/Finished Pharmaceuticals/Adulterated.
  • 2Issuing office: Center for Drug Evaluation and Research (CDER).
  • 3Laboratory controls and testing: 18 source-text matches.
  • 4Quality systems and CAPA: 10 source-text matches.
Laboratory controls and testingQuality systems and CAPAManufacturing and CGMP controlsData integrity and recordsLabeling, claims, and misbranding

Suggested next step

Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAHTMLUpdated Jul 30, 2026

FDA source document

Read the full FDA warning letter

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Common questions about the Intas Pharmaceuticals Limited warning letter

What does this warning letter mean for Intas Pharmaceuticals Limited?

Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on March 30, 2026.

What happens after an FDA warning letter?

The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.