Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistBioStem Life Sciences received a warning letter for manufacturing human cellular products derived from umbilical cord (OROPRO®, PROVISCUS®, NEOFYL®) and amniotic membrane products (RHEO®) in violation of current good manufacturing practice (CGMP) requirements under 21 CFR parts 210 and 211 and the Federal Food, Drug, and Cosmetic Act. An FDA inspection conducted September 11-15, 2023, documented significant deviations in the company's methods, facilities, and controls for manufacturing, processing, packing, and holding these products, resulting in their classification as adulterated drugs. The violations rendered the products prohibited for sale in interstate commerce under section 301(k) of the FD&C Act.