FDA Inspection
Bio-Medical Instrument CoBio-Medical Instrument Co – FDA Inspection, Nov 30, 2011
Record Details
This FDA Inspection record concerns Bio-Medical Instrument Co, with an inspection on November 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bio-Medical Instrument Co
- Inspection Date
- November 30, 2011
- Product Type
- Devices
View Company Profile
ID · df462951-86f4-497c-bfdb-81ee89da5fce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 759522
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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