FDA Inspection
Hangzhou Wan-mei Dental Laboratory, Ltd.Hangzhou Wan-mei Dental Laboratory, Ltd. – FDA Inspection, Apr 29, 2010
Record Details
This FDA Inspection record concerns Hangzhou Wan-mei Dental Laboratory, Ltd., with an inspection on April 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 29, 2010
- Product Type
- Devices
View Company Profile
ID · f14c4eb1-91da-44bb-bb62-f561da606818
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 659706
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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.