FDA Inspection
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTDWUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD – FDA Inspection, Oct 19, 2017
Record Details
This FDA Inspection record concerns WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD, with an inspection on October 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7064016d-0a00-4d65-8ebb-ec8f6527c105
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029455
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2019 | Not classified | Office of Inspections and Investigations |
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