Cipla gets 6 USFDA observations for Maha facility
Mumbai: Cipla has received six inspectional observations in Form 483 from the United States Food and Drug Administration (USFDA) at the conclusion of a routine current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of the Company located in Patalganga, Maharashtra, India.
The inspection was held from 28th March 2024 to 4th April 2024.
"The Company will work closely with the USFDA and is committed to address these comprehensively within the stipulated time," Cipla stated.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. Khwaja Abdul Hamied founded the Company in 1935 in Mumbai. Cipla has extended its presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. The Company is also deepening its presence in the key markets of India, South Africa, and the U.S. among other economies of the emerging world.
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