FDA Inspection
BioMedica Diagnostics IncBioMedica Diagnostics Inc – FDA Inspection, Jun 22, 2011
Record Details
This FDA Inspection record concerns BioMedica Diagnostics Inc, with an inspection on June 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioMedica Diagnostics Inc
- Inspection Date
- June 22, 2011
- Product Type
- Devices
View Company Profile
ID · da2a1030-13bf-45a8-bf57-4d60af9ab0c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734427
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of BioMedica Diagnostics Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BioMedica Diagnostics Inc
- FDA Inspection 925181 - 2015-05-01
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