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 382213
Gujarat
IndiaFEI 3004011473Issued Jul 28, 2023Center for Drug Evaluation and Research | CDER
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 3004011473.
Violations5
Issue DateJul 28, 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 382213
Gujarat
India
FEI Number
3004011473
Country
India
Issue Date
July 28, 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 violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The FDA inspection from November-December 2022 identified critical failures in the quality control unit's oversight, including inadequate controls over CGMP documents, deficient computerized system controls, insufficient laboratory investigations, and data integrity deficiencies in production and laboratory departments. Senior facility managers failed to exercise proper authority and responsibility to ensure reliable data generation, demonstrating that the quality assurance function was not adequately performing its oversight role.
Intas Pharmaceuticals Limited FDA Warning Letter, July 28, 2023
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