FDA Inspection
Biophotas, IncBiophotas, Inc – FDA Inspection, Apr 6, 2016
Record Details
This FDA Inspection record concerns Biophotas, Inc, with an inspection on April 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biophotas, Inc
- Inspection Date
- April 6, 2016
- Product Type
- Devices
View Company Profile
ID · 2d5a1414-a733-4652-922c-350dca4a8007
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 967749
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
- 21 CFR 50.25(c)ClincialTrials.gov statement
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biophotas, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Biophotas, Inc
- FDA Inspection 1074241 - 2018-11-27
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