FDA Inspection
Maple Industries LLCMaple Industries LLC – FDA Inspection, Nov 19, 2010
Record Details
This FDA Inspection record concerns Maple Industries LLC, with an inspection on November 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Maple Industries LLC
- Inspection Date
- November 19, 2010
- Product Type
- Devices
View Company Profile
ID · 945d5c37-63cd-44c3-8844-d3c28a85533b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 698984
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate 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 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
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