The USFDA inspection covered 3 units at Kurkumbh plant.
Cipla, on March 31, said it has received eight good manufacturing practices observations from the US health regulator after inspection of Kurkumbh plant, Maharashtra.The US Food and Drug Administration (USFDA) conducted a product specific pre-approval (PAI) and Good Manufacturing Practices (GMP) inspection at company's Kurkumbh plant from March 11
to 20, 2019.
The inspection covered three units at the plant.
"Post the conclusion of the inspection, the company received 8 GMP observations and also received 10 observations pertaining to the PAI for a novel technology product slated for approval beyond 2024," Cipla said in its BSE filing.
These observations are both product specific and GMP observations related to the manufacturing and quality processes, it added. "There are no data integrity (DI) observations."The company said it is committed to addressing these observations and would submit its response to the agency within the stipulated time.
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