FDA Inspection
Lords Dental Studio, Inc.Lords Dental Studio, Inc. – FDA Inspection, May 11, 2011
Record Details
This FDA Inspection record concerns Lords Dental Studio, Inc., with an inspection on May 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lords Dental Studio, Inc.
- Inspection Date
- May 11, 2011
- Product Type
- Devices
View Company Profile
ID · c24297fc-6175-42eb-9ad9-6984460f24b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 725324
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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