FDA Inspection
Access Dental Lab, LLCAccess Dental Lab, LLC – FDA Inspection, Jun 28, 2021
Record Details
This FDA Inspection record concerns Access Dental Lab, LLC, with an inspection on June 28, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Access Dental Lab, LLC
- Inspection Date
- June 28, 2021
- Product Type
- Devices
View Company Profile
ID · a2436508-7e65-4376-a080-e8781c00f420
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1145271
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
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