DentiMax , IncMarch 10, 2023

FDA 483 - DentiMax , Inc - March 10, 2023

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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.

Company: DentiMax , Inc
Inspection Date: March 10, 2023
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Charles L. Larson (investigator)

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ID · 823375d2-7cb6-43e4-aad3-8a3ee3df5f65