FDA Inspection
Biocare Medical, LLCBiocare Medical, LLC – FDA Inspection, Apr 27, 2015
Record Details
This FDA Inspection record concerns Biocare Medical, LLC, with an inspection on April 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biocare Medical, LLC
- Inspection Date
- April 27, 2015
- Product Type
- Devices
View Company Profile
ID · dc59bcd2-0daa-49e6-8816-d5dd4ff81451
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 923342
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biocare Medical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biocare Medical, LLC
- FDA Inspection 961525 - 2016-01-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.