FDA Inspection
Maanshan Bond Medical Instruments Co., LTD.Maanshan Bond Medical Instruments Co., LTD. – FDA Inspection, Oct 22, 2015
Record Details
This FDA Inspection record concerns Maanshan Bond Medical Instruments Co., LTD., with an inspection on October 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 22, 2015
- Product Type
- Devices
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ID · c9917077-3882-48d8-9da9-ce456ff6161b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948093
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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