1Other quality system
Immediate or timely action to mitigate risk and prevent reoccurence is not always taken.
Inspection Record
The American National Red Cross — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The Quality Assurance'review is not being completed within 5 business days.
3Regulatory reporting and change control
The firm's use ofrepetitive cycles ofsubmissions and rejections ofCorrective Action Plans and the use oftime extensions without limits is suspending the 30 day time frame to provide timely corrective actions.
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.
