FDA Inspection
Event Medical LtdEvent Medical Ltd – FDA Inspection, Apr 16, 2010
Record Details
This FDA Inspection record concerns Event Medical Ltd, with an inspection on April 16, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Event Medical Ltd
- Inspection Date
- April 16, 2010
- Product Type
- Devices
View Company Profile
ID · 82ffc8e1-4a5b-42ca-955a-1069c4ced746
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 661820
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40(b)Document changes, review and approval, communication
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(b)Procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 820.30(g)Design validation unresolved discrepancies
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