FDA Inspection
Changzhou DSB Medical Co., Ltd.Changzhou DSB Medical Co., Ltd. – FDA Inspection, Oct 20, 2016
Record Details
This FDA Inspection record concerns Changzhou DSB Medical Co., Ltd., with an inspection on October 20, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c25255ea-cfbc-4ed6-845c-162b39ce0c33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994499
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Changzhou DSB Medical Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Changzhou DSB Medical Co., Ltd.
- FDA Inspection 836113 - 2013-06-06
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