483
Reproductive Health CenterFDA 483 - Reproductive Health Center - February 06, 2019
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.
Record Details
During an inspection, the FDA observed that Reproductive Health Center in Tucson, AZ, failed to establish procedures for HCT/P donor screening, specifically for Zika Virus. Additionally, the firm did not maintain complete documentation of donor screening results for communicable diseases. These issues indicate deficiencies in their quality system for human reproductive tissue.
Open in Dashboard
ID · 511d3e89-ab11-489e-838d-59f18eb8b334