USFDA completes inspection of Biocon drug substance unit at Bengaluru

No Observations

Banglore: 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," the spokesperson said.

Earlier Medical Dialogues has reported that Biotechnology firm Biocon said it has received Establishment Inspection Report (EIR) from the US health regulator on the closure of inspection of its sterile drug product manufacturing facility in Bengaluru.

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