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USFDA completes inspection of Biocon’s drug substance unit at Bengaluru

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The week-long audit concluded without any observations and no Form 483 was issued

Biotechnology major Biocon has said the inspection of its drug substance manufacturing site at Bengaluru campus by the US health regulator has concluded without any observations.

“The United States Food and Drug Administration (USFDA) conducted a periodic current good manufacturing practice (cGMP) inspection of our drug substance manufacturing site at Bengaluru campus from Sep 17-21, 2018,” Biocon spokesperson said in a statement.

The week-long audit concluded without any observations and no Form 483 was issued, it added.

“The successful audit of this site reflects our strong commitment to cGMP compliance,” spokesperson said.

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