Cipla gets 1 inspectional observation from USFDA for Maha facility
Mumbai: Pharma giant Cipla has informed through a recent BSE filing that the Company has received 1 inspectional observation in Form 483 from the United States Food and Drug Administration (USFDA) at the conclusion of the inspection at Kurkumbh manufacturing facility.
The inspection was held from 29th April, 2024 to 8th May, 2024.
“A routine current Good Manufacturing Practices (cGMP) inspection was conducted by
the United States Food and Drug Administration (USFDA) at manufacturing facility of the Company located
in Kurkumbh, Maharashtra, India from 29th April, 2024 to 8th May, 2024,” 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.
“The
Company will work closely with the USFDA and is committed to address this observation comprehensively
within stipulated time,” Drug major added.
In April, the Medical Dialogues team reported that Cipla received six inspectional observations in Form 483 from the USFDA at the conclusion of a routine current Good Manufacturing Practices (cGMP) inspection at the company’s manufacturing facility located in Patalganga, Maharashtra, India.
Read also: Cipla gets 6 USFDA observations for Maha facility
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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