1Material and supplier control
Failure (b)(4) to notify FDA's Baltimore District Office and/or CBER within 45 days after learning that a unit of unsuitable blood or blood component was distributed.
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
The firm's entitled that they must develop a problems and within 45 meet these time frames for the follOWing problems: a.
3Other quality system
Written standard operating procedures were not followed.
4Other quality system
The firm failed to promptly, thoroughly and adequately investigate l correct and take steps to prevent the recurrence of each problem.
5Material and supplier control
The firm failed to notify ~onsignee and/or FDA's Baltimore District Office within 48 hours after learning that a unit of unsuitable blood or blood component has been distributed.
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.
