Biocon Biologics Bengaluru Unit: USFDA Voluntary Action Indicated
Oct 30, 2024 17:07
Biocon Biologics' Bengaluru drug substance facility has been classified as voluntary action indicated by the USFDA following a cGMP inspection. The action relates to rh-Insulin (rhI) drug substance supply to the US.
Photograph: Kind courtesy Biocon Biologics/Facebook
New Delhi, Oct 30 (PTI) Biocon Biologics on Wednesday said its drug substance facility in Bengaluru has been classified as voluntary action indicated by the US Food and Drug Administration.
Biocon Biologics' drug substance facility is located at Biocon Campus, (Site 1) in Bengaluru, the company said in a statement.
"This relates to the cGMP inspection conducted by the agency between February 20-28, 2024 and pertains to the supply of rh-Insulin (rhI) drug substance to the United States," it added.
Biocon Biologics remains committed to global standards of quality and compliance, the company said.
Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the USFDA.
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