# FDA 483 - UW ICU Medical Limited - April 04, 2019

Source: https://www.keypedia.com/records/483/uw-icu-medical-limited/5cfd5e0e-6acd-4666-8206-8a84b859882e

> FDA 483 for UW ICU Medical Limited on April 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UW ICU Medical Limited
- Inspection Date: 2019-04-04
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of UW ICU Medical Limited in Weihai, China, identified several deficiencies in their quality system. Observations included inadequate documentation of rework activities and validated processes, as well as poorly established procedures for environmental controls and internal quality audits. These findings indicate a need for the firm to enhance its compliance with medical device manufacturing regulations.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/uw-icu-medical-limited/e5500850-cb1f-4947-96db-ca493f94e327

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