FDA Inspection
Merz North America, Inc.Merz North America, Inc. – FDA Inspection, Dec 23, 2010
Record Details
This FDA Inspection record concerns Merz North America, Inc., with an inspection on December 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Merz North America, Inc.
- Inspection Date
- December 23, 2010
- Product Type
- Devices
View Company Profile
ID · 2ea36a07-0581-4953-92c7-78ebc87f0f90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702452
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Merz North America, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2017 | Not classified | Minneapolis District Office | |
| September 2, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 19, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 8, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Merz North America, Inc.
- FDA Inspection 1034616 - 2017-05-25
- FDA Inspection 893657 - 2014-09-02
- FDA Inspection 834443 - 2013-04-19
- FDA Inspection 715962 - 2011-04-08
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