MiMedx Injectables Don’t Meet Regulatory Standards Despite Claim to FDA - News Summed Up

MiMedx Injectables Don’t Meet Regulatory Standards Despite Claim to FDA


MiMedx Group’s injectable wound-care products don’t meet regulatory standards, including for purity and sterility, more than two years after the company told the Food and Drug Administration it had complied with the requirements, according to internal documents. The biomedical company continued to sell injectable tissue products to health-care providers such as the Veterans Health Administration after the FDA identified 13 manufacturing deficiencies, raising pressure on a company whose growth has been curbed in recent years...


Source: Wall Street Journal May 23, 2019 23:31 UTC



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