# FDA 483 - Diasol, Inc - June 28, 2021

Source: https://www.globalkeysolutions.net/records/483/diasol-inc/789f4a22-f0b9-4dba-a6a7-273a1e1c58c2

> FDA 483 for Diasol, Inc on June 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diasol, Inc
- Inspection Date: 2021-06-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Diasol, Inc., a medical device manufacturer in Phoenix, AZ, from June 7-28, 2021. The inspection revealed significant deficiencies in the firm's quality system, including failures to document corrective and preventive actions, maintain device history records, perform quality audits, and conduct regular management reviews. These issues indicate a lack of control over critical quality processes.

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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/diasol-inc/a519e617-eb8a-4638-87b1-6f632d5c44b8

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6