FDA Inspection
Verathon Medical UlcVerathon Medical Ulc – FDA Inspection, Feb 14, 2014
Record Details
This FDA Inspection record concerns Verathon Medical Ulc, with an inspection on February 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Verathon Medical Ulc
- Inspection Date
- February 14, 2014
- Product Type
- Devices
View Company Profile
ID · f0f73758-8366-4b65-97d6-e2aa5ec8b004
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 867165
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Verathon Medical Ulc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Verathon Medical Ulc
- FDA Inspection 1026546 - 2017-08-04
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