Division 9.2 Complaints

All complaints and other information, including serious adverse reactions and serious adverse events, which may suggest that defective blood components have been issued, shall be documented, carefully investigated for causative factors of the defect and, where necessary, followed by recall and the implementation of corrective actions to prevent recurrence. Procedures shall be in place to ensure that the competent authorities are notified as appropriate of serious adverse reactions or serious adverse events in accordance with regulatory requirements.