FDA Inspection
Fastsize, LlcFastsize, Llc – FDA Inspection, Jan 19, 2010
Record Details
This FDA Inspection record concerns Fastsize, Llc, with an inspection on January 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fastsize, Llc
- Inspection Date
- January 19, 2010
- Product Type
- Devices
View Company Profile
ID · 98187106-90a4-4b23-a439-80929ceea9f2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 634810
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
14- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.181(a)DMR device specifications
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