US FDA issues 11 observations each for two sites in Bengaluru: Biocon

Biocon Ltd said the US health regulator has issued Form 483s with 11 observations each for two sites in Bengaluru and six observations for a plant in Malaysia

Biocon Ltd on Wednesday said the US health regulator has issued Form 483s with 11 observations each for two sites in Bengaluru and six observations for a plant in Malaysia, following inspection of seven manufacturing facilities of its arm Biocon Biologics.

As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The USFDA conducted three on-site inspections of Biocon Biologics' seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia, Biocon said in a regulatory filing.

The inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022, it added.

"At the conclusion of these inspections, the agency has issued Form 483s with 11 observations each for the two sites in Bengaluru and six observations for the Malaysia site," the company said.

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, it added.

Biocon said the inspections were 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," it added.

The company said it 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," it added.