FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193)

Biocon Sdn. Bhd. in Iskandar Puteri, Malaysia, was cited for significant deficiencies in its drug substance and drug product manufacturing facility. Observations included inadequate aseptic processing controls, unvalidated cleaning procedures for non-product contact equipment, and insufficient quality unit oversight. Additionally, the firm's deviation investigations were found to be inadequate, water and process (b)(4) systems were not assured for intended use, and batch record documentation practices were poor.