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BIOCON'S BENGALURU PLANT'S INSPECTION COMPLETED BY USFDA

Updated: Dec 06, 2018

As per the reports, during an inspection of US vascular's medical device manufacturing facility at Beaverton by US FDA, there have been 11 contraventions of good manufacturing practices, as per a FDA warning letter.

The inspection of the new manufacturing facility of Biocon was completed by USFDA without any findings. In a Regulatory filing, Biocon said "A pre-compliance investigation was conducted for our new manufacturing facility of oral solid dosage forms at Biocon Park in Bengaluru was conducted by The United States food and drug administration (USFDA) from November 5-9 2018".

The inspection was finished without any observation and Form 483 was not issued. Form 483 is issued by USFDA to inform to inform the management of the company of any unacceptable condition at its manufacturing facility. After completion of the inspection, the form is issued.

Biocon's shares were trading .27 percent lower at 638.70 apiece on the BSE.