USFDA inspection: Cipla gets 8 observations for Pithampur facility
Mumbai: Cipla has recently announced that the United States Food and Drug Administration (USFDA) has issued 8 inspectional observations in Form 483 after an inspection at the company's Pithampur manufacturing facility.
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 inspection was conducted from 6th – 17th February, 2023.
"We hereby notify that the United States Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at our Pithampur manufacturing facility from 6th – 17th February, 2023. On conclusion of the inspection, the Company has received 8 inspectional observations in Form483.", the company informed in a BSE filing.
"The Company will work closely with the USFDA and is committed to address these comprehensively within stipulated time", Cipla stated.
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.
The company specializes in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments. Cipla's 47 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to 86 markets.
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