The USFDA, which inspected Biocon’s insulins facility in Johar, Malaysia last month, has found certain deviations related to production, quality, lab controls and facility and equipment systems.
The facility was inspected between February 6 and February 15 as part of pre-approval inspection and was issued six Form 483 observations.
The Malaysian unit, run under the Mylan-Biocon partnership, is largely focused on insulin variants. Biocon and Mylan have together filed for USFDA approval of long acting Insulin Glargine from this facility.
USFDA inspectors issue observations on Form 483 at the end of the site inspection outlining any deviations of current good manufacturing practices. The company then will have to file its response in 15 days providing corrective and preventive action plan referred as CAPA.
If the company responds to the satisfaction, the USFDA issues an establishment inspection report (EIR) indicating closure of the inspection.