Inspection Record

American Red Cross Blood Services — FDA 483 Findings

US FDAInspected 2015-07-11Published 2024-01-17 3 findingsMaterial and supplier controlEquipment and facilityOther quality system

View the regulator's official source The source document is always the basis for judgement.

Findings

1Material and supplier control

Failure to adequately investigate, correct, and prevent recurring problem of distributing blood and blood components without ice to consignees.

2Equipment and facility

Failure to sign and date equipment validation/revalidation records.

3Other quality system

", Written procedure was not followed regarding handling of "Management of Suspect Products".

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.

Other records for this company

2015-07-11 · US FDA · 8 findings2015-07-11 · US FDA · 3 findings2015-07-23 · US FDA · 7 findings2015-07-11 · US FDA · 5 findings
American Red Cross Blood Services company profile — full history US FDA documents, 2024 Go to Findings search