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Biocon says US FDA issued 11 observations each for firm's two sites in Bengaluru

These include multiple drug substance and drug product facilities and other support infrastructure at these sites.

August 31, 2022 / 07:36 PM IST

Biotechnology firm Biocon said on August 31 that the US health regulator has issued 11 observations each after inspecting its two sites in Bengaluru. The US FDA also issued six observations for the pharma company's Malaysia site.

Biocon informed the stock exchanges that these 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.

At the conclusion of these inspections, the agency has issued Form 483s with 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site, the Kiran Mazumdar Shaw-led company said in a regulatory filing.

Speaking on US FDA's move, a company spokesperson said that the observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerised tools to aid risk assessment and investigations, and other procedural and facility upgrades.

"We will submit Corrective and Preventive Action Plans (CAPA) to the US FDA 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," the spokesperson added.


Last month, the company had received three US FDA observations after inspecting its Telangana-based manufacturing plant.

Shares of Biocon on Tuesday had closed 1.75 percent higher at Rs 308.80 apiece on BSE. The stock market was closed on August 31 on account of the Ganesh Chaturthi festival.
Moneycontrol News
first published: Aug 31, 2022 07:36 pm
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