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Greater Chesapeake and Potomac Region
FDA Inspection: none available at this time SNIPPET | DOWNLOAD
Recalls and Significant Blood Safety Violations
10/30/09 Region collected 197 overweight units of whole blood but logged only 95 of them as problems in the Automated Problem Management System (APMS). In addition to not logging the other 102 occurrences, ARC did not investigate and correct them, as required. Approximately 18 months earlier, the FDA had cited the Region for its failure to correct and prevent the collection of overweight units. 10/30/09 ARC reported to the FDA that for an undetermined length of time, the Region had been excluding another category of problems from the PM SOP requirements. Those problems involved autologous or directed units of blood that have labeling discrepancies. The number of occurrences is undetermined, and the Region has not maintained documentation related to the discrepancies or its communications with consignees. 10/30/09 Region failed to conduct a thorough investigation to determine the root cause for the improper distribution of units that were associated with a whole blood number mix-up. 10/30/09 Ten Red Blood Cells, Leuko Reduced, Irradiated units were distributed without a required second person review. 10/30/09 Major risk problem was discovered for an ABO discrepancy associated with a whole blood number mix-up. 10/30/09 Major risk problem was discovered for failure to perform required record reviews resulting in failure to discover that quality control function checks were not performed on three collection scales. The scales were used during collection of 122 platelets units, of which 12 were distributed. 10/30/09 Region identified an adverse trend in whole blood number mix-ups, but failed to develop a formal corrective action to prevent recurrence. 10/30/09 Recalled 2 Platelets Pheresis Leukocytes Reduced Products due to component preparation (plateletpheresis product did not meet specification for platelet yield). 10/30/09 Recalled 1 Platelets Pheresis Leukocytes Reduced Product due to component preparation (product had insufficient plasma to support the platelet yield and therefore did not meet specifications). 10/30/09 Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for residence in a malarial risk area). 10/30/09 Recalled 1 Platelets Pheresis leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area). 10/30/09 Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to assure that donor met acceptance criteria for hematocrit & body temperature). 10/30/09 Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for medication use). 10/30/09 Recalled 1 Platelets Product due to donor eligibility (failure to defer donor for medication use). 10/30/09 Recalled 138 Platelets Pheresis Products due to component preparation 10/30/09 Recalled 25 Platelets Pheresis Irradiated due to component preparation (plateletpheresis product did not meet specification for platelet yield). Food and Drug Administration Adverse Determination Letter (ADL) There are no Inspection Reports currently available for this region.
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Food and Drug Administration Adverse Determination Letter (ADL)