Nagl MedTechSeptember 20, 2022

FDA 483 - Nagl MedTech - September 20, 2022

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Record Details

Naglreiter Consulting, LLC, a contract manufacturer in Miramar, FL, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate supplier controls, unvalidated manufacturing processes, and failures in design validation and risk analysis documentation. The firm also failed to adequately establish procedures for device history records.

Company: Nagl MedTech
Inspection Date: September 20, 2022
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Karen M. Rodriguez (investigator)

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ID · 5ab9ff74-4c49-48fd-ad53-3292492467df