Vivex Biologics, Inc.December 18, 2015

FDA 483 - Vivex Biologics, Inc. - December 18, 2015

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Record Details

UMTB Biomedical, Inc. in Miami, FL, a human tissue establishment, was cited for failing to validate its processing activities, including cleaning, cutting, freezing, drying, and sterilizing of human tissue products. This is a repeat observation from a previous inspection, indicating a persistent issue with ensuring effective processes to prevent infectious disease contamination and cross-contamination.

Company: Vivex Biologics, Inc.
Inspection Date: December 18, 2015
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
People: Shavon L. Square (issuing_officer)
Samantha J. Pinizzotto (investigator)

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ID · 4b8c7277-5546-4b80-9814-dc05babfa071