FDA Inspection
Changzhou Orthmed Medical Instrument Co., Ltd.Changzhou Orthmed Medical Instrument Co., Ltd. – FDA Inspection, May 30, 2013
Record Details
This FDA Inspection record concerns Changzhou Orthmed Medical Instrument Co., Ltd., with an inspection on May 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 30, 2013
- Product Type
- Devices
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ID · 0c5ab3bb-43dc-45cf-88b4-e89a83e1e71a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838678
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
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Other FDA inspections of Changzhou Orthmed Medical Instrument Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2017 | Not classified | Office of Inspections and Investigations |
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