Biocon Sdn. Bhd. (Company No. 201101002193) – FDA 483, Sep 24, 2021

An FDA inspection of Biocon Sdn. Bhd. (FEI 3011248248), a drug substance and drug product manufacturer located at No. 1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, 79200 Iskandar Puteri, Johor, Malaysia, was conducted from September 13 to September 24, 2021. The inspection identified six observations.

Observation 1 noted that the vessel and distribution system for a drug product were not qualified/validated, and the water for injection (WFI) system was not qualified/validated.

Observation 2 detailed inadequate aseptic behavior and monitoring during drug product manufacture. Specifically, Restrictive Access Barrier (RAB) environmental monitoring plates were not sanitized prior to entry into Grade A space, and the environmental monitoring process design for the filling machine was inadequate to minimize interventions. Additionally, personnel environmental monitoring was only representative of the last EM plate change.

Observation 3 stated that facilities and equipment were not adequately validated and maintained. This included product contact surface materials of construction not being maintained in a qualified state, evidenced by discoloration (rouge) on vessel sidewalls. A deteriorated floor seam and leaks at a drain line and another line were also observed, with no work orders in place. Furthermore, the raw materials warehouse area was not validated for 20-25°C storage.

Observation 4 indicated that cleaning validations for