The US Food and Drug Administration (FDA) visited Biocon’s Bangalore, Karnataka site in India between March 27 and April 7 and issued a Form 483 with eight observations.
Among the issues, the Agency observed discrepancies between manufacturing information submitted by Biocon and the actual practice, with notable issues surrounding the quality assurance unit.
“The Quality assurance unit has approved and implemented documents that do not assure appropriate production, testing, and deviation review and release of commercial material,” the Form states.
It also cites a lack of quality oversight in the review of procedures followed in the quality control testing of an undisclosed drug substance and drug product.
“Observations on form 483 is a standard outcome of any audit. Biocon has already responded to USFDA on all observations of the recent audit within stipulated timelines,” a Biocon spokesperson said in a statement sent this morning to in-Pharmatechnologist.
“Biocon has a good track record of inspections by the USFDA, European regulators and other regulators from developed and emerging markets.”
The firm did not respond to further questions from this publication, saying “as a policy we do not comment on any schedule or outcomes of regulatory inspections, unless we believe that there is a material impact.”
The site – located at Plot No.2-4, Phase IV, Bommasandra-Jigani Link Road in the Biocon Special Economic Zone – makes a number of products including atorvastatin, the active ingredient in cholesterol-lowering statins. The site also makes large molecule products including insulin glargine.