FDA 483 - Medidenta International Inc - November 05, 2025

Medidenta, a medical device manufacturer in Las Vegas, Nevada, was inspected and cited for significant deficiencies in its quality system. The inspection revealed failures to adequately establish and follow procedures for servicing activities and to maintain complete service records for its AW25C and AW30C Autoscalers. Additionally, the firm failed to establish adequate procedures for device history records, lacking documentation to demonstrate devices were manufactured according to the device master record and met specifications.