# FDA 483 - Wells Johnson Company - February 26, 2020

Source: https://www.globalkeysolutions.net/records/483/wells-johnson-company/57a4425f-a8b1-475b-8e3e-7860466053fd

> FDA 483 for Wells Johnson Company on February 26, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wells Johnson Company
- Inspection Date: 2020-02-26
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Wells Johnson Company, a medical device manufacturer in Tucson, AZ, revealed significant deficiencies in their quality system. Observations included inadequate complaint investigation records, insufficient documentation of corrective and preventive actions, and infrequent management reviews of the quality system's effectiveness. These findings indicate a need for improved adherence to regulatory requirements for medical device manufacturing.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/wells-johnson-company/8c748970-0bb5-4566-abfd-dc82ec9355e5

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