FDA Inspection
3D and Company LLC3D and Company LLC – FDA Inspection, May 13, 2015
Record Details
This FDA Inspection record concerns 3D and Company LLC, with an inspection on May 13, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3D and Company LLC
- Inspection Date
- May 13, 2015
- Product Type
- Devices
View Company Profile
ID · 3c163efd-8a39-4345-9f77-26a4074c14b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 928981
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design validation- 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 803.17Lack of Written MDR Procedures
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