FDA Inspection
Smith Companies Dental ProductsSmith Companies Dental Products – FDA Inspection, Jan 28, 2010
Record Details
This FDA Inspection record concerns Smith Companies Dental Products, with an inspection on January 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 28, 2010
- Product Type
- Devices
View Company Profile
ID · 88aa5fb7-6a62-4c4d-abc4-f522060f7d8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645092
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.30(b)Establish the design and development plan
- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.75(a)Documentation
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