1Quality unit oversight
Your firm's QA-approved Corrective actions and Effectiv eness Checks are not always c ompleted in the manner that they were designed and approved for.
Inspection Record
American Red Cross Blood Services — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Corrective Action Plans are not always reviewed by Q A within 5 days as required.
3Other quality system
Your firm does not always perform Effectiveness Checks, developed as part of the formal corrective Action Plan (CAP) for Redacted (b)(4) Problems Redacted (b)(4) Problems and for Trends by their due date.
4Other quality system
Your firm failed to follow your written procedure Redact ed (b)(4) in that y ou do not always submit a copy ofthe Monthly Summary'Report to the Medical Director as required prior to sub1milttin.g them to BHQ ..
5Other quality system
Corrective Action Plans developed to prevent the recurrence of problems are not always submitted to the Quality Assurance Department within 30 calinder days of the date of problem discovery as required.
6Other quality system
Your written defines those steps to be followed when investigating a problem at ARC.
7Deviation, CAPA, and investigation
Your firm has failed to thoroughly and adequately investigate, develop root cause, correct and take steps to prevent the recurrence of biological product deviations (BPD).
About this record
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
