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USFDA issues two observations for Cipla's Indore plant

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Last Updated : Jul 05 2022 | 10:17 AM IST

Following a Pre-Approval Inspection

Cipla announced that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) at the Company's Indore plant from 27 June 2022 to 1 July 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.

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First Published: Jul 05 2022 | 9:49 AM IST

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