Company
United StatesMedela Inc, Mchenry, IL – FDA Inspections
Inspection records and compliance data for Medela Inc in Mchenry, Illinois. 8 FDA inspections on record (2 OAI), last inspected August 27, 2014.
Company Profile
This profile covers Medela Inc based in Mchenry, Illinois, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 2
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected April 2, 2009. Last inspected August 27, 2014.
Most cited issue areas
- Analysis of data/reports from data sources1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design output - documentation1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 27, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 893426 |
| February 26, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 869654 |
| May 25, 2012 | OAI | Foods & Cosmetics, Medical Devices & Rad Health · Foodborne Biological Hazards | 779907 |
| November 21, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 755250 |
| August 9, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 747437 |
| November 1, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 696530 |
| January 21, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 648376 |
| April 2, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 573015 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Medela Inc
FEI Number
1419937
Address
1101 Corporate Dr, Mchenry, Illinois 60050, United States
Country
United States
ID: c3a05e54-356f-4189-94af-b0e6246c6dbd