FDA 483 - Sperm Bank, Inc - June 12, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Sperm Bank, Inc. in San Diego, CA, revealed significant deficiencies in donor eligibility determination and communicable disease testing practices. The firm failed to collect donor specimens at appropriate times and did not adequately test repeat anonymous semen donors for West Nile Virus (WNV) during the required season. Additionally, the company's internal protocols and donor screening forms were found to be outdated and insufficient for ensuring compliance with WNV screening requirements.
ID · e7cff2cc-9784-4f3e-8fbe-fccae6a890f1