FDA Inspection
Guangzhou Fortunique LimitedGuangzhou Fortunique Limited – FDA Inspection, Nov 14, 2013
Record Details
This FDA Inspection record concerns Guangzhou Fortunique Limited, with an inspection on November 14, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Guangzhou Fortunique Limited
- Inspection Date
- November 14, 2013
- Product Type
- Devices
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ID · c0b82515-9f4e-44a6-813e-4a93ded75ae1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 856751
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.184(d)Acceptance records
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Other FDA inspections of Guangzhou Fortunique Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2018 | Not classified | Office of Inspections and Investigations |
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