483
Refine USA, LLCFDA 483 - Refine USA, LLC - August 16, 2023
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Record Details
Refine USA, LLC, a specification developer in Jacksonville, FL, was cited for inadequate purchasing controls during an FDA inspection. The firm failed to ensure that purchased products and services conform to specified requirements. This was evidenced by a contract manufacturer making an unapproved change to the Class II "Rejuvpen NXT" device without notifying Refine USA, LLC, affecting an estimated (b)(4) units.
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ID · 028708dd-020f-4e4f-a32b-45868dd37779