The US Food and Drug Administration (FDA) conducted the investigation of Biocon’s facility during two separate visits, on February 7-8 and 11-15, 2019.
The pre-approval inspection was conducted in Biocon’s facility, based in Bangalore, India, which contains a newly built injectable manufacturing line for a ‘biologic drug product’, according the company.
After its inspection, the FDA issued a Form 483 and noted two observations that require action.
The first observation related to the procedures designed to prevent microbiological contamination of drug product, which the FDA noted were not followed.
FDA inspectors noted that operators of the fill-finish line did not perform visual inspections for integrity breaches.
The second observation outlined problems with investigations into unexplained discrepancies. The report noted, “Environmental monitoring excursion investigations and corrective actions…lacked effective CAPAs (continual improvement of the process).”
In order to rectify the observations, FDA recommendations included the provision of training concerning aseptic practices, and analysis to be conducted regarding the design of the laminar airflow hood (LAF), used in the testing process.
On February 18, Biocon acknowledged receiving the Form 483 in a public statement and outlined that it planned to “address these [observations] expeditiously.”
A spokesperson for the company confirmed that the company had addressed the observations and responded to the regulator.
As the observations were made during a pre-approval inspection, there will no impact on the company’s supply of products, the spokesperson added.
The current issues follow on from prior feedback from the FDA, made public in August 2017, which saw the company receive eight observations regarding the quality assurance unit at the site.