FDA Inspection
Tyco Healthcare CanadaTyco Healthcare Canada – FDA Inspection, Oct 15, 2010
Record Details
This FDA Inspection record concerns Tyco Healthcare Canada, with an inspection on October 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tyco Healthcare Canada
- Inspection Date
- October 15, 2010
- Product Type
- Devices
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ID · 9c8dc161-8675-44d7-96c2-d14bc0d764e1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 695153
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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