FDA 483 - Boston Scientific Medical Device (Malaysia) Sdn. Bhd. - May 22, 2026
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Boston Scientific Medical Device (Malaysia) Sdn. Bhd., a medical device manufacturer in Seberang Perai Selatan, Malaysia, was cited for significant deficiencies in its laboratory controls and quality system. The inspection revealed inadequate investigations into recurring analytical failures, incomplete laboratory records for testing and equipment, and insufficient controls over the issuance and use of analytical worksheets, raising concerns about data accuracy and integrity.
- Inspection Date
- May 22, 2026
- Product Type
- Device
- Office
- Office of Partnerships
- Person
ID · 937dc9f5-c58b-4009-843c-3f5ca23b19b6