FDA Inspection
Wake Forest Baptist Health- Blood Bank HospitalWake Forest Baptist Health- Blood Bank Hospital – FDA Inspection, Nov 19, 2009
Record Details
This FDA Inspection record concerns Wake Forest Baptist Health- Blood Bank Hospital, with an inspection on November 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 19, 2009
- Product Type
- Devices
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ID · fd6a9572-6880-48a5-9c38-2bc6141b647c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 632319
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 803.30(a)(1)Report of Death Within 10 Days
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wake Forest Baptist Health- Blood Bank Hospital
9| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2024 | Not classified | Atlanta District Office | |
| March 11, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 14, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 20, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 17, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Wake Forest Baptist Health- Blood Bank Hospital
- FDA Inspection 1249368 - 2024-09-11
- FDA Inspection 1164773 - 2022-03-11
- FDA Inspection 1036762 - 2017-12-14
- FDA Inspection 966437 - 2016-04-20
- FDA Inspection 887836 - 2014-07-17
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