FDA Inspection
Combo AGCombo AG – FDA Inspection, Sep 11, 2014
Record Details
This FDA Inspection record concerns Combo AG, with an inspection on September 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Combo AG
- Inspection Date
- September 11, 2014
- Product Type
- Devices
View Company Profile
ID · 41f6af8c-e02c-4358-8fbe-afe0ec4e9edb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 898410
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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