FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - September 24, 2021

Biocon Sdn. Bhd. in Iskandar Puteri, Johor, Malaysia, a drug substance and drug product manufacturer, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate qualification and validation of manufacturing systems, poor aseptic practices, insufficient material testing, facility and equipment maintenance issues, deficient cleaning validations, and an inadequate out-of-trend investigation procedure. These issues indicate a lack of control over critical manufacturing processes and facility conditions.