483
Gergens Orthodontic Lab, Inc.Gergens Orthodontic Lab, Inc. – FDA 483, Mar 30, 2023
Record Details
An FDA inspection of Gergens Orthodontic Lab, Inc., a medical device manufacturer in Phoenix, AZ, revealed a significant lapse in quality system management. The firm was cited for failing to perform quality audits, specifically noting that no internal audits had been conducted since 2019. This indicates a fundamental issue with the firm's quality assurance processes.
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ID · a06c6445-bb30-4915-93ca-6bf6a701b151
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