FDA Inspection
Dongguan Prestige Sporting Goods Co., Ltd.Dongguan Prestige Sporting Goods Co., Ltd. – FDA Inspection, Dec 7, 2015
Record Details
This FDA Inspection record concerns Dongguan Prestige Sporting Goods Co., Ltd., with an inspection on December 7, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 7, 2015
- Product Type
- Devices
View Company Profile
ID · 5ce0f6b3-5cb7-4327-8762-059c23bed89f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955436
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dongguan Prestige Sporting Goods Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Dongguan Prestige Sporting Goods Co., Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.