Cipla arm gets zero Form 483 observations from USFDA for USA facility
Mumbai: Cipla has recently announced that the US Food and Drug Administration has concluded inspection with zero Form 483 observations at the Fall River facility of the Company's wholly-owned subsidiary InvaGen Pharmaceuticals.
The inspection was conducted from 24th April, 2023 to 1st May, 2023.
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.
The Company specializes in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments. Cipla's 47 manufacturing sites worldwide produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to 86 markets.
