Company
United StatesAnimas Corporation, West Chester, PA – FDA Inspections
Inspection records and compliance data for Animas Corporation in West Chester, Pennsylvania. 4 FDA inspections on record, last inspected January 27, 2016.
Company Profile
This profile covers Animas Corporation based in West Chester, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 10, 2011. Last inspected January 27, 2016.
Most cited issue areas
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 27, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 966243 |
| October 8, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 900703 |
| April 12, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 833476 |
| August 10, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 745496 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Animas Corporation
FEI Number
3002920072
Address
200 Lawrence Dr, West Chester, Pennsylvania 19380, United States
Country
United States
ID: 60ab3113-f41d-431b-8fb6-80b164679ff0