483
XIROS LtdFDA 483 - XIROS Ltd
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Record Details
An FDA inspection of Xiros Ltd., a manufacturer of Class II medical devices, revealed two significant observations. The firm failed to validate its sterilization process for devices distributed in the U.S. market. Additionally, Xiros Ltd. lacked quality agreements with its sterilization suppliers, preventing notification of product or service changes.
- Company
- XIROS Ltd
- Product Type
- Device
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ID · d2c91870-1b3e-46b1-b967-d2382932d108