Presbyterian/St. Luke's Medical Center Donor Services – FDA 483, Jan 26, 2017
HealthOne Presbyterian/St. Luke's Medical Center's hospital blood bank was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate record-keeping practices, including failure to document technician identities, maintain concurrent records, and conduct thorough investigations into discrepancies. Additionally, the facility failed to adhere to standard operating procedures for blood component processing and ensure proper donor consent for apheresis procedures.
- Inspection date
- January 26, 2017
- Product type
- biologics
ID · 0dfa5f02-ee8a-4a25-88ce-5a70fa488795
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