FDA Inspection
Bio-Med U.S.A., Inc.Bio-Med U.S.A., Inc. – FDA Inspection, Jan 23, 2013
Record Details
This FDA Inspection record concerns Bio-Med U.S.A., Inc., with an inspection on January 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bio-Med U.S.A., Inc.
- Inspection Date
- January 23, 2013
- Product Type
- Devices
View Company Profile
ID · 7ea88cd0-4518-458c-8658-a0ea9098f0ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816798
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bio-Med U.S.A., Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bio-Med U.S.A., Inc.
- FDA Inspection 672514 - 2010-07-19
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