PSM Medical SolutionsJuly 24, 2019

FDA 483 - PSM Medical Solutions - July 24, 2019

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Record Details

During an inspection, PSM Medical Solutions, a medical device manufacturer in Gunningen, Germany, was cited for failing to establish procedures for design validation. This deficiency was specifically noted in the design of their PSM BENEfit/quattro Screws, indicating a significant lapse in their product development quality system. The firm's own procedure defined design validation, but the necessary procedures were not implemented.

Company: PSM Medical Solutions
Inspection Date: July 24, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Thai T. Duong

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ID · b303c4a2-b201-40da-b84e-ecdbfdf1d195