483
Boston Scientific Medical Device (Malaysia) Sdn. Bhd.Boston Scientific Medical Device (Malaysia) Sdn. Bhd. – FDA 483, Nov 9, 2018
Record Details
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.
- Inspection date
- November 9, 2018
- Product type
- device
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ID · a8d5e19f-d732-4033-9e8c-71ee0c5f0a4b
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