FDA Inspection
BayCare Health Systems IRBBayCare Health Systems IRB – FDA Inspection, Feb 19, 2014
Record Details
This FDA Inspection record concerns BayCare Health Systems IRB, with an inspection on February 19, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- BayCare Health Systems IRB
- Inspection Date
- February 19, 2014
- Product Type
- Biologics
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ID · 0ca22917-f33c-46be-b0c3-4c512f3b2553
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868214
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(5)List of members
- 21 CFR 50.25(a)(7)Whom to contact
- 21 CFR 56.113Reporting
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 13, 2014 | VAI | Center for Devices and Radiological Health | 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 867058 - 2014-02-13
- FDA Inspection 844253 - 2013-08-07
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