FDA 483 - DCI Donor Services - December 19, 2019

An FDA inspection of DCI Donor Services in West Sacramento, CA, a human tissue establishment, revealed significant deficiencies in donor screening and facility procedures. The firm failed to adequately screen placenta donors for communicable diseases like West Nile Virus and lacked proper written procedures for HCT/P donor eligibility determinations, including for Zika Virus. Additionally, the facility did not follow its established cleaning and decontamination procedures for surgical recovery suites.