FDA Inspection
Anhui JBH Medical Apparatus Co. Ltd.Anhui JBH Medical Apparatus Co. Ltd. – FDA Inspection, Sep 11, 2025
Record Details
This FDA Inspection record concerns Anhui JBH Medical Apparatus Co. Ltd., with an inspection on September 11, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 11, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · bf9c0523-e0ee-4f62-ad48-82bba6aa20d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1281378
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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