Neodontics IncJanuary 17, 2020

FDA 483 - Neodontics Inc - January 17, 2020

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Record Details

Neodontics Inc, a medical device manufacturer in Sun Valley, CA, was inspected by the FDA from January 16-17, 2020. The inspection revealed a significant issue regarding the maintenance of device history records for its Dental Alloys products. This indicates a fundamental lapse in quality system documentation.

Company: Neodontics Inc
Inspection Date: January 17, 2020
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Sarah A. Hassas (investigator)

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