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The USFDA has completed the inspection of its new manufacturing facility in Bengaluru without any observation.
“The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection of our new oral solid dosage forms manufacturing facility at Biocon Park in Bengaluru from November 5-9, 2018,” Biocon said in a regulatory filing today.
The audit was concluded without any observation and no Form 483 was issued. A Form 483 is issued by the USFDA to notify a company’s management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.
Shares of Biocon were trading 0.27 per cent lower at Rs 638.70 apiece on the BSE.
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