Company
United StatesInControl Medical, LLC, Pewaukee, WI – FDA Inspections
Inspection records and compliance data for InControl Medical, LLC in Pewaukee, Wisconsin. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected February 14, 2017.
Company Profile
This profile covers InControl Medical, LLC based in Pewaukee, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected August 21, 2012. Last inspected February 14, 2017.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design output - Lack of or inadequate procedures1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1016485 |
| July 17, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 840481 |
| August 21, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 795977 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
InControl Medical, LLC
FEI Number
3009466220
Address
N22w24021 Cloister Cir # 1f, Pewaukee, Wisconsin 53072-6791, United States
Country
United States
ID: 42053149-a27e-4714-8c2e-6fa5dbcb43da