DCI Donor Services dba Sierra Donor Services Eye Bank – FDA EIR, Feb 1, 2018

A comprehensive FDA inspection of DCI Donor Services dba Sierra Donor Services Eye Bank (SDSEB) in Nashville, TN, was conducted from January 29 to February 1, 2018. This human ocular tissue establishment underwent a review covering facilities, tissue recovery, donor eligibility (screening and testing), processing, labeling, storage, and distribution. The inspection also encompassed a detailed examination of donor charts, complaint records, deviation logs, environmental monitoring, temperature records, equipment maintenance, and standard operating procedures. The inspection, performed under CP 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s), concluded with no significant objectionable conditions identified. Consequently, no FDA Form 483, which lists inspectional observations, was issued. The facility’s previous inspection in October 2015 also resulted in no objectionable conditions. During the closeout meeting, management was reminded of their ongoing responsibilities to comply with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. No specific corrective actions were mandated as a result of this inspection. SDSEB continues to be registered with the FDA and is a member of the American Association of Tissue Banks.