FDA Inspection
Applied Ozone SystemsApplied Ozone Systems – FDA Inspection, Oct 9, 2009
Record Details
This FDA Inspection record concerns Applied Ozone Systems, with an inspection on October 9, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Applied Ozone Systems
- Inspection Date
- October 9, 2009
- Product Type
- Devices
View Company Profile
ID · b7483313-b5e3-4933-9645-ea91ba5f8f32
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 619984
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
18- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
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