Company
United StatesEnhancement Medical, LLC, Milwaukee, WI – FDA Inspections
Inspection records and compliance data for Enhancement Medical, LLC in Milwaukee, Wisconsin. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected January 15, 2014.
Company Profile
This profile covers Enhancement Medical, LLC based in Milwaukee, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected January 15, 2014.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design validation - user needs and intended uses1 inspection
- Design verification - output does not meet input requirement1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 15, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 863009 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Enhancement Medical, LLC
FEI Number
3008404291
Address
10201 W Innovation Dr Ste 450, Milwaukee, Wisconsin 53226, United States
Country
United States
ID: 57f360b8-2e09-4c77-8299-86a4f5a6a46d