Wake Forest Baptist Health- Blood Bank Hospital, Winston Salem, NC – FDA Inspections
Inspection records and compliance data for Wake Forest Baptist Health- Blood Bank Hospital in Winston Salem, North Carolina. 10 FDA inspections on record (1 OAI), last inspected September 11, 2024.
This profile covers Wake Forest Baptist Health- Blood Bank Hospital based in Winston Salem, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 1
- VAI
- 0
- NAI
- 8
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 19, 2009. Last inspected September 11, 2024.
Most cited issue areas
- Adverse events--all info not in file1 inspection
- Lack of System for Determining MDR Events1 inspection
- Report of Death Within 10 Days1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 11, 2024 | Not classified | Biologics | 1249368 |
| March 11, 2022 | NAI | Biologics · Blood and Blood Products | 1164773 |
| December 14, 2017 | NAI | Biologics · Blood and Blood Products | 1036762 |
| April 20, 2016 | NAI | Biologics · Blood and Blood Products | 966437 |
| July 17, 2014 | NAI | Biologics · Blood and Blood Products | 887836 |
| June 14, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 787067 |
| December 15, 2011 | NAI | Biologics · Blood and Blood Products | 760124 |
| September 16, 2010 | NAI | Biologics · Blood and Blood Products | 681920 |
| May 26, 2010 | NAI | Biologics · Blood and Blood Products | 664576 |
| November 19, 2009 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 632319 |
No Form 483s, Warning Letters or EIRs on record.
Companies with similar regulatory profiles, compliance history, and operations.
Name
Wake Forest Baptist Health- Blood Bank Hospital
FEI Number
1071670
Address
Hospital Blood Bank 1st Floor North Tower, Medical Center Blvd, Winston Salem, North Carolina 27157, United States
Country
United States
ID: 71baa1f0-434d-4c6f-baae-7cce9c71be52