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Shares of Biocon tumbled 6 per cent today as the biotechnology major said the US health regulator had made seven observations after inspecting its sterile drug product manufacturing facility in Bengaluru.
The stock plunged 5.81 per cent to Rs 624.90 on the BSE. On the NSE, shares of the company dropped 5.97 per cent to Rs 624.30.
The observations are largely procedural and aimed at continuous improvement, Biocon had said in a filing to BSE yesterday.
The USFDA had completed pre-approval inspection of the sterile drug product manufacturing facility in Bengaluru this week and issued a Form 483 with 7 observations, the filing said.
“We will respond to the USFDA with a corrective and preventive action plan in a timely manner,” a Biocon spokesperson said.
An FDA Form 483 is issued to a company’s management after the conclusion of an inspection by the USFDA. It notifies the company’s management of objectionable conditions at the facility.
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