FDA Inspection
BayCare Health Systems IRBBayCare Health Systems IRB – FDA Inspection, Feb 13, 2014
Record Details
This FDA Inspection record concerns BayCare Health Systems IRB, with an inspection on February 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BayCare Health Systems IRB
- Inspection Date
- February 13, 2014
- Product Type
- Devices
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ID · 0a3707c0-0be4-4038-bfc0-7f8fb05c5c2b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867058
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.107(d)One non-affiliate member
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BayCare Health Systems IRB
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | NAI | Bioresearch Monitoring | |
| December 21, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 19, 2014 | VAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| August 7, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for BayCare Health Systems IRB
- FDA Inspection 1243796 - 2024-06-28
- FDA Inspection 1037984 - 2017-12-21
- FDA Inspection 868214 - 2014-02-19
- FDA Inspection 844253 - 2013-08-07
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