Company
United StatesMallinckrodt Manufacturing LLC, Madison, WI – FDA Inspections
Inspection records and compliance data for Mallinckrodt Manufacturing LLC in Madison, Wisconsin. 3 FDA inspections on record, last inspected March 13, 2015.
Company Profile
This profile covers Mallinckrodt Manufacturing LLC based in Madison, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 17, 2010. Last inspected March 13, 2015.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design validation - documentation1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 13, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 919255 |
| October 21, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 752094 |
| August 17, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 676845 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Mallinckrodt Manufacturing LLC
FEI Number
3004531588
Address
6603 Femrite Dr, Madison, Wisconsin 53718, United States
Country
United States
ID: d780261e-cb4d-456e-ac86-b8014775bdb6