# FDA 483 - Itamar Medical Ltd. - January 13, 2011

Source: https://www.keypedia.com/records/483/itamar-medical-ltd/006f6be0-e5ef-401f-be20-e69e750d2b24

> FDA 483 for Itamar Medical Ltd. on January 13, 2011. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Itamar Medical Ltd.
- Inspection Date: 2011-01-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Itamar Medical Ltd. in Caesarea, Israel, was cited for multiple deficiencies related to its design control processes for a medical device project, including inadequate design plans, input documentation, output documentation, verification, transfer, and validation. Additionally, the firm failed to adequately establish procedures for complaint handling and maintain complete complaint records. These issues indicate significant gaps in the firm's quality system for device design and post-market surveillance.

## Related Documents

- [483 - 2011-01-10](https://www.keypedia.com/records/483/itamar-medical-ltd/433d4f01-a055-4e51-8fee-493fd60d2c2e)

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-k-larson/6b398c12-db13-4f7f-9995-dfbcf34b0118)

Company: https://www.keypedia.com/companies/itamar-medical-ltd/f93825a4-10ad-4dd8-a011-3e4a8370ec76

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