FDA 483 - Specialty Blood Center - June 21, 2018

Vitrologic, Inc., dba Specialty Sera, in Charleston, SC, was inspected and received a Form 483 with 10 observations. The inspection revealed significant deficiencies in donor management, including failure to notify deferred donors, maintain donor deferral records, and ensure donor safety during collection. Additionally, issues were noted in product labeling and the establishment and adherence to standard operating procedures for recordkeeping and emergency services.