FDA Inspection
CANADIAN GENERAL FILTERS LIMITEDCANADIAN GENERAL FILTERS LIMITED – FDA Inspection, Mar 16, 2023
Record Details
This FDA Inspection record concerns CANADIAN GENERAL FILTERS LIMITED, with an inspection on March 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 426897c4-53a7-4f04-b343-20d8a3847055
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1201102
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(j)Design history file
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