Cipla Goa facility gets 6 USFDA observations
Mumbai: Pharma major, Cipla, has received six inspectional observations in Form 483 from the US Food and Drug Administration (USFDA) after the inspection at the Company's manufacturing facility in Goa, India.
The inspection was conducted from 10th – 21st June 2024.
"The Company will work closely with the USFDA and is committed to address these comprehensively within stipulated time," Cipla informed in a BSE filing.
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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Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. It has strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments. It has 47 manufacturing sites around the world which produces 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to its 80+ markets.
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