483
Prollenium Medical Technologies Inc.Prollenium Medical Technologies Inc. – FDA 483, Nov 9, 2023
Record Details
An FDA inspection of Prollenium Medical Technologies Inc. in Richmond Hill, a manufacturer of class III dermal fillers, revealed significant deficiencies in its quality system. The firm was cited for inadequate process validation, insufficient in-process product control, and flawed risk analysis for its Revanesse products. Additionally, issues were identified with the establishment and control of acceptable suppliers and contractors.
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ID · d96f5a4f-e4fb-4721-8a85-9142d9bddb36
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