1Other quality system
Iril.porting blood product procedures are not adequate: a.
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
Procedures related to managing the NDDR (Directive: Management o f the National Donor Deferral Register 14.2.014 and WI: Manually Updating the Nati onal Do nor De fe rral Register 14.3.160) do not instruct how to manage donors with hyp henated names.
3Material and supplier control
The Component Labeling Job Aid is based on a 2006 validation study titled "Product Quality Study Plan For ABO/Rh Labeling of Blood Components Version BSL 09-286, 12/29/2005." The study's purpose was to alleviate documentation by providing labeling staff with maximum time limits for labeling a set number of components outside controlled storage at one time.
4Other quality system
On 8/17/10, we (SK, DA) observed donor self-administered questions being conducted without visual privacy at a bloodmobile using two self-contained buses.
5Other quality system
On 8/17/10, I (DA) observed donor REDACTION (b)(6) was not appropriately ass essed for travel regarding question #30 (travel for a total of 3 months or more to U.K .
6Other quality system
There is no job aid (or other procedure/iristruction) to assist employees in determining the total transit time for blood products received into inventocy.
7Other quality system
Per 14.3.081 (Reviewing Registered Donations), the registration reviewers are required to review the "Before Images Created During Registration Report" to assure that former n ames listed on the BDR were created during registration.
8Stability and storage
When importing blood products, determining whether products were out of controlled storage for no more than 30 minutes is not accurately calculated and does not document the.actual end time.
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.
