# FDA 483 - Qualitel Corporation - December 05, 2019

Source: https://www.globalkeysolutions.net/records/483/qualitel-corporation/a7c81258-d343-4c0f-b331-a0aaa57c21ff

> FDA 483 for Qualitel Corporation on December 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qualitel Corporation
- Inspection Date: 2019-12-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Qualitel Corporation, a contract manufacturer of Class II medical devices in Everett, WA, was inspected by the FDA from December 2-5, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning inadequate procedures for corrective and preventive actions, device history records, and equipment maintenance. These findings indicate a lack of adherence to established quality system requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.globalkeysolutions.net/companies/qualitel-corporation/43b702fc-1bd7-4869-8675-d96d02b784a0

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822