# FDA 483 - XIROS Ltd - Unknown Date

Source: https://www.keypedia.com/records/483/xiros-ltd/d2c91870-1b3e-46b1-b967-d2382932d108

> FDA 483 for XIROS Ltd on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: XIROS Ltd
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/xiros-ltd/cf685830-d8ab-470e-8e74-6fb22c85b6ef

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd