# FDA 483 - Westmed, Inc. - December 11, 2019

Source: https://www.globalkeysolutions.net/records/483/westmed-inc/50370a12-7104-412b-909f-6af974b3bf0b

> FDA 483 for Westmed, Inc. on December 11, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Westmed, Inc.
- Inspection Date: 2019-12-11
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Westmed, Inc. in Tucson, AZ, a medical device manufacturer, revealed two significant observations. The firm failed to document corrective and preventive action (CAPA) activities following a product recall, and records of complaint investigations were incomplete. These issues are considered serious as they relate to quality system requirements and product safety.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/westmed-inc/0d999e50-c2aa-49cf-ac37-123c84f600ea

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face