FDA Inspection
BSN Medical, Inc.BSN Medical, Inc. – FDA Inspection, Oct 10, 2012
Record Details
This FDA Inspection record concerns BSN Medical, Inc., with an inspection on October 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BSN Medical, Inc.
- Inspection Date
- October 10, 2012
- Product Type
- Devices
View Company Profile
ID · be06c812-7276-41e8-864b-c44d0daaa7b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801687
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 820.184DHR content
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of BSN Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BSN Medical, Inc.
- FDA Inspection 1018136 - 2017-04-26
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