FDA 483 - Maimonides Medical Center - August 15, 2024

An FDA inspection of Maimonides Medical Center's Blood Bank & Donor Room identified significant deficiencies in record-keeping practices. The firm failed to concurrently maintain detailed records for blood and blood component collection and processing, impacting traceability and donor eligibility determinations. Issues included inadequate donor verification, illegible documentation, unapproved validation records, and improper use of correction tape on quality control records.