The inspection by the US Food and Drug Administration (FDA) involved Biocon’s Johor, Malaysia, insulin glargine drug substance, drug product and device assembly facilities. The issues were discovered between June 24 and July 5, 2019.
A spokesperson for the company said in a statement that “We will respond to the FDA with a Corrective and Preventive Action Plan and are confident of addressing these observations expeditiously.”
According to the spokesperson, the company does ‘not expect’ any change to the commercialization plans for insulin glargine in the US.
The statement concluded that “Biocon remains committed to global standards of quality and compliance.”
The company is obliged to respond to the US FDA’s observations within 15 days. The FDA has not yet released the inspection report to detail what the observations were related to.
Biocon's Malaysia facility was set up in 2015 with an investment of $275m (€249.15m) and, according to the company, it is the largest integrated insulin manufacturing facility in Asia, with approximately 600 employees.
The facility, which was current good manufacturing process (cGMP)-approved by Malaysia’s National Pharmaceutical Control Bureau in 2015, manufactures the drug substance for Biocon’s range of rh-insulin and insulin analogs, as well as drug products in vials and cartridges.
In March 2019, Biocon received another Form 483 with two observations, related to insufficient prevention of microbiological contamination and data discrepancies, regarding an injectables manufacturing facility in Bangalore, India.
The observations also followed a pre-approval inspection, in this case the company stated that it had addressed the issues and had responded to the regulator.