FDA Inspection
Committee for Protection of Human Subjects, UCBCommittee for Protection of Human Subjects, UCB – FDA Inspection, Nov 15, 2013
Record Details
This FDA Inspection record concerns Committee for Protection of Human Subjects, UCB, with an inspection on November 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 15, 2013
- Product Type
- Devices
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ID · aefbadfd-b51b-47d3-bf59-a163919e06e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857513
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 50.25(b)(1)Statement of risks
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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Other FDA inspections of Committee for Protection of Human Subjects, UCB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Committee for Protection of Human Subjects, UCB
- FDA Inspection 1009426 - 2017-02-23
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