FDA 483 - One Umbilical Cord Lab, Inc. - March 12, 2020

One Umbilical Cord Lab, Inc. in Richardson, TX, a manufacturer of human tissue and biological drugs, received a Form 483 with 14 observations. The firm was cited for significant deficiencies including failure to use FDA-licensed donor screening tests for communicable diseases, inadequate donor eligibility determinations, and a lack of validated aseptic processes. Additionally, the inspection revealed severe issues with sterility failure investigations, environmental controls, quality control unit authority, product stability testing, and record retention, indicating systemic failures in ensuring product safety and quality.