FDA Inspection
Global Blood Resources, LLCGlobal Blood Resources, LLC – FDA Inspection, May 23, 2012
Record Details
This FDA Inspection record concerns Global Blood Resources, LLC, with an inspection on May 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Global Blood Resources, LLC
- Inspection Date
- May 23, 2012
- Product Type
- Devices
View Company Profile
ID · 706f9aa1-e878-44b4-a134-b9a6f5aa5cfb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 787319
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Global Blood Resources, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 1, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 9, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Global Blood Resources, LLC
- FDA Inspection 1227150 - 2024-01-17
- FDA Inspection 1090950 - 2019-05-01
- FDA Inspection 900024 - 2014-10-09
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.