Biocon Biologics Biocon Campus (Site 1) facility gets 4 USFDA observations
Bangalore: Biocon has recently announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483s with 4 observations at the conclusion of the inspection at the Biocon Biologics Limited’s Biocon Campus (Site 1) 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 between February 20-28, 2024.
This inspection pertains exclusively to the rh-Insulin (rhI) Drug Substance (DS) supply to a customer for
veterinary use.
“The trigger for this inspection was a Pre-Approval Supplement (PAS) filed by our customer
late last year,” the Company’s Spokesperson said in a BSE filing.
“The Company will
submit a comprehensive Corrective and Preventive Action (CAPA) Plan to the U.S. FDA within the stipulated
time and is committed to addressing these observations expeditiously.
The outcome of this inspection at Site 1 does not impact the manufacturing and distribution of the
Company’s commercial products in the US market.
Biocon Biologics remains committed to global standards of Quality and Compliance.” he added.
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Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company.
BBL has acquired the global biosimilars business of its long-standing partner Viatris. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., EU, Australia, Canada, Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, and other noncommunicable diseases.
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