As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
“The US Food and Drug Administration (USFDA) conducted three on-site inspections of
Biologics’ seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia,” Biocon said in a statement.
The inspections started with the Bengaluru site on August 11, 2022, and concluded with the Malaysia site on August 30, 2022.
The inspections were triggered on account of three pre-approval inspections for biosimilar Bevacizumab, rh-Insulin and Insulin Aspart and a capacity expansion inspection for biosimilar Trastuzumab. These included multiple drug substance and drug product facilities and other support infrastructure at these sites, Biocon said.
The biopharmaceutical company said that they will submit Corrective and Preventive Action Plans (CAPA), to the USFDA in the stipulated time frame.
“We do not expect the outcome of these inspections to impact the current supply of our products. Biocon Biologics remains committed to global standards of quality and compliance,” it added.
At 11.23 am, the scrip was trading 2 per cent lower at Rs 303.40 over the last day’s closing of Rs 309.65 a piece. The stock has fallen over 14 per cent in the past one year, and is down over 16.46 per cent so far in 2022.
For the quarter ended June 30 2022, the company reported consolidated sales of Rs 2,139.5 crore, up 21.56 per cent from the year-ago quarter’s Rs 1,760 crore. The company reported net profit of Rs 210 crore for the latest quarter.