483
Prestige MedicalFDA 483 - Prestige Medical - October 24, 2019
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Record Details
Prestige Medical, a Class II medical device manufacturer in Northridge, CA, received a Form 483 for several quality system deficiencies. The inspection revealed issues with management review of the quality system, inadequate complaint handling, and insufficient supplier record maintenance. Additionally, the firm failed to properly identify non-conforming products, indicating a need for comprehensive quality management improvements.
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ID · 61d5575b-ce36-449a-b0ec-c58f463151dc