U.S. FDA Flags Quality, Procedural Lapses At Biocon Biologics’ Facilities


The U.S. drug regulator has flagged quality and procedural lapses across Biocon Ltd. subsidiary’s three sites.

“The U.S. Food and Drug Administration conducted three on-site inspections of Biocon Biologics Ltd.’s seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia. These inspections started with the Bengaluru site on Aug. 11, 2022 and concluded with the Malaysia site on Aug. 30,” the parent said in an Aug. 31 exchange filing.

“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.”

A Form 483 is issued when investigators have observed any condition that in their judgment may constitute violation of the Food Drug and Cosmetic Act and related acts.

These inspections, the filing had said, were triggered for three pre-approval inspections for biosimilar Bevacizumab (cancer), rh-Insulin and Insulin Aspart (diabetes) and a capacity expansion inspection for biosimilar Trastuzumab (stomach cancer). These included multiple drug substance and drug product facilities and other support infrastructure at these sites.

“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,” the company had said in the filing.

The drugmaker also said it would submit corrective and preventive action plans to the U.S. FDA in the stipulated time frame. “We do not expect the outcome of these inspections to impact the current supply of our products.”

The observations had caused Biocon’s shares to decline on Sept. 1.

BQ Prime has obtained a copy of the observations from the FDA on the three drug substance and product manufacturing sites.


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