FDA Inspection
Shenzhen Yi Lang Dental Peizhi Co. Ltd.Shenzhen Yi Lang Dental Peizhi Co. Ltd. – FDA Inspection, Oct 13, 2010
Record Details
This FDA Inspection record concerns Shenzhen Yi Lang Dental Peizhi Co. Ltd., with an inspection on October 13, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 13, 2010
- Product Type
- Devices
View Company Profile
ID · deb76ab4-f45c-4180-b892-55b0011bc690
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697842
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
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