Intas Pharmaceuticals Limited

Warning LetterOpen

Mr. Nimish Chudgar Chief Executive Officer & Managing Director Intas Pharmaceuticals Limited Plot No. 255, Magnet Corporate Park, Near Sola Bridge, S.G. Highway Thaltej, Ahmedabad 380054 Gujarat IndiaFEI 3003157498Issued Nov 21, 2023Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003157498.

Violations4

Issue DateNov 21, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Intas Pharmaceuticals Limited
Location: Mr. Nimish Chudgar Chief Executive Officer & Managing Director Intas Pharmaceuticals Limited Plot No. 255, Magnet Corporate Park, Near Sola Bridge, S.G. Highway Thaltej, Ahmedabad 380054 Gujarat India
FEI Number: 3003157498
Country: India
Issue Date: November 21, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Intas Pharmaceuticals Limited's drug manufacturing facility in India was found to have committed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their products adulterated. The company's quality control unit failed to exercise adequate oversight, and investigators discovered that visual inspectors systematically manipulated particle defect counts and other quality data on inspection records since 2021 to artificially keep batches within acceptable limits and avoid deviations. Multiple operators engaged in this data manipulation to circumvent proper deviation investigations and maintain compliance appearances. The violations demonstrated a breakdown in quality assurance and production department controls that failed to ensure the reliability of drug product quality data.

Intas Pharmaceuticals Limited FDA Warning Letter, November 21, 2023