FDA Inspection
B.F. Wehmer Company, Inc.B.F. Wehmer Company, Inc. – FDA Inspection, Feb 10, 2012
Record Details
This FDA Inspection record concerns B.F. Wehmer Company, Inc., with an inspection on February 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- B.F. Wehmer Company, Inc.
- Inspection Date
- February 10, 2012
- Product Type
- Devices
View Company Profile
ID · 831b2f7c-3301-43f7-b400-9e884ae67582
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 768008
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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