Company
United StatesMerz North America, Inc., Franksville, WI – FDA Inspections
Inspection records and compliance data for Merz North America, Inc. in Franksville, Wisconsin. 5 FDA inspections on record, last inspected May 25, 2017.
Company Profile
This profile covers Merz North America, Inc. based in Franksville, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 23, 2010. Last inspected May 25, 2017.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design plans- updated1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 25, 2017 | Not classified | Medical Devices & Rad Health | 1034616 |
| September 2, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 893657 |
| April 19, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 834443 |
| April 8, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 715962 |
| December 23, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 702452 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Merz North America, Inc.
FEI Number
3003407669
Address
4133 Courtney Rd Ste 10, Franksville, Wisconsin 53126, United States
Country
United States
ID: ee93b71a-c4d2-49d8-b449-c82b3df15397