FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - July 20, 2023

An FDA inspection of Biocon Sdn. Bhd.'s drug and device manufacturing facility in Johor, Malaysia, conducted from July 10-20, 2023, revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations, as documented in an FDA Form 483.

For drug manufacturing, repeat observations included inadequate procedures to prevent microbiological contamination during sterile production, such as blocked aseptic airflow and insufficient sanitization of equipment. The company also failed to conduct integrity testing for stoppers and vials, compromising sterility assurance for distributed injectable products. Investigations into out-of-trend stability results and out-of-specification laboratory findings were consistently deficient, with scientifically unjustified root causes and a failure to retest affected batches. Environmental controls were inadequate, lacking written procedures for managing differential pressure losses in aseptic areas. Furthermore, test method transfers were not properly validated, incoming component quality was not routinely verified, and refresher CGMP training for Process Research & Development personnel was lacking.

Regarding medical devices, the inspection found an inadequate risk analysis for controlling and testing the injection force of a finished product, despite receiving over 1600 complaints about the device failing to administer medication. Corrective and preventive actions (CAPA) for these device issues were inadequately documented and failed to comprehensively test retention samples.

Biocon Sdn. Bhd. is required to provide a detailed response to the FDA outlining corrective and preventive actions to address these observations and ensure compliance with regulatory standards.