FDA Inspection
Battle Creek Manufacturers IncBattle Creek Manufacturers Inc – FDA Inspection, Feb 5, 2009
Record Details
This FDA Inspection record concerns Battle Creek Manufacturers Inc, with an inspection on February 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 5, 2009
- Product Type
- Devices
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ID · a21e589a-b922-4088-843b-a0cb49fccca5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 554274
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
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Other FDA inspections of Battle Creek Manufacturers Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 25, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Battle Creek Manufacturers Inc
- FDA Inspection 798047 - 2012-09-10
- FDA Inspection 713121 - 2011-02-25
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