# FDA 483 - DentiMax , Inc - March 10, 2023

Source: https://www.globalkeysolutions.net/records/483/dentimax-inc/823375d2-7cb6-43e4-aad3-8a3ee3df5f65

> FDA 483 for DentiMax , Inc on March 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DentiMax , Inc
- Inspection Date: 2023-03-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: DentiMax, Inc., a medical device manufacturer in Mesa, AZ, was inspected by the FDA from March 8-10, 2023. The inspection revealed two significant issues related to quality system procedures. Specifically, the firm failed to maintain complete complaint investigation records and lacked documentation for the evaluation of new suppliers for dental sensors.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/dentimax-inc/3bbeea11-6c03-4742-b6be-0d3f780b019f

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