Cipla update on USFDA inspection of its Kurkumbh plant
Cipla announced on 31 March 2019 that the US FDA conducted a product specific pre-approval
(PAI) and Good Manufacturing Practices (GMP) inspection at its Kurkumbh plant from 11 March 2019
to 20 March 2019. The inspection covered 3 units at the plant.
Post the conclusion of the inspection, the Company received 8 GMP observations. The Company also received 10 observations pertaining to the PAI for a novel technology product slated for approval beyond 2024.
These observations are both product specific and GMP observations related to the manufacturing and quality processes. There are no data integrity (DI) observations.
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First Published: Apr 02 2019 | 10:22 AM IST