FDA 483 - Boston Scientific Medical Device (Malaysia) Sdn. Bhd. - November 09, 2018

An FDA inspection of Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Bandar Cassia, Malaysia, revealed two significant observations. The firm failed to validate critical mixing processes used in the manufacturing of LOTUS Edge Valve Implants. Additionally, process control procedures for these implants were incomplete, lacking requirements for documenting all operations in the electronic Device History Record.