|
The United States Food and Drug Administration (USFDA) has issued Form 483s with 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site.
The inspections started with the Bengaluru site on 11 August, 2022 and concluded with the Malaysia site on 30 August 2022.
The pharma major said 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.
The observations are primarily related to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools to aid risk assessment & investigations and other procedural & facility upgrades, said the company.
The drug maker said in a statement, “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.”
Biocon is a global biopharmaceutical company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer, and autoimmune.
The biotech company's consolidated net profit surged 71.1% to Rs 144.40 crore on 21.5% jump in revenue from operations to Rs 2,139.50 crore in Q1 FY23 over Q1 FY22.
|