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483
•Viera Fertility Center•June 5, 2019

Viera Fertility Center – FDA 483, Jun 5, 2019

Record Details

An FDA inspection of Viera Fertility Center in Melbourne, FL, revealed a significant deficiency in their documentation practices. The firm failed to adequately document procedures for testing, screening, and determining donor eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This issue specifically impacts their processes for anonymous and directed egg and sperm donors.

Company
Viera Fertility Center
Inspection date
June 5, 2019
Product type
biologics
Office
Office of Medical Device and Radiological Health Division II
Person
  • Barbara T. Carmichael (Investigator at U.S.FDA)
View Company Profile

ID · 950d1377-077b-4d27-aca4-0966fa9ac4f2

Other documents for Viera Fertility Center
  • 483 - 2023-02-03February 3, 2023

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