07-05-2022 10:36 AM | Source: Accord Fintech
USFDA conducts pre-approval inspection at Cipla`s Indore plant
United States Food and Drug Administration (USFDA) has conducted a Pre-Approval Inspection (PAI) at the Cipla’s Indore plant from June 27, 2022 to July 01, 2022. The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at the said plant. There is no data integrity observation. The PAI is part of the routine business operations and the company is committed to addressing these observations and will submit its response to USFDA within the stipulated time.
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.
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