Trouble Mounts For Biocon’s Bengaluru Plant
The U.S. FDA after its June inspection issued Form 483 observations to Biocon for its Bengaluru unit.
Biotechnology major Biocon Ltd. received observations from U.S. health regulator pertaining to issues over manufacturing practices at its Bengaluru plant following an inspection in June, according to Chicago-based FDAzilla, which collects information from the FDA.
The regulator issued Form 483 observations after Sandra Hughes and Eileen Liu, officials with the U.S. Food and Drug Administration (U.S. FDA), conducted an inspection between May 25 and June 3, FDAzilla said on its website. Form 483 is used by the FDA to document and communicate concerns discovered during plant inspections.
This U.S. FDA visit was a part of the surveillance audit for a small molecule injectable, a Biocon spokesperson said in a statement. “The company has responded to the regulator with a Corrective and Preventive Action Plan (CAPA) and is on track to implement them in a timely manner,” this statement added.
Earlier in response to a specific query emailed by BloombergQuint, Biocon had said, “As a policy we do not comment on the schedule or outcomes of regulatory inspections, unless we believe that there is a material impact. In all such inspections where any observations have been made, Biocon has responded to the observations within stipulated timelines.”
Earlier, the U.S. FDA had inspected the biotechnology major’s Bengaluru plant between March 27 and April 7, post which it issued Form 483 with eight observations. Besides, the French regulator found concerns with sterile products, biological medicinal products, packaging and quality control testing at the Biocon unit, according to a report filed on the European Medicines Agency’s website.