Company
United StatesSynthes, Inc., West Chester, PA – FDA Inspections
Inspection records and compliance data for Synthes, Inc. in West Chester, Pennsylvania. 6 FDA inspections on record (1 OAI), last inspected November 13, 2013.
Company Profile
This profile covers Synthes, Inc. based in West Chester, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected April 27, 2009. Last inspected November 13, 2013.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Documentation1 inspection
- Evaluation Codes1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 13, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 859106 |
| May 16, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 831886 |
| October 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 806156 |
| September 15, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 732622 |
| October 8, 2009 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 620039 |
| April 27, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 581756 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Synthes, Inc.
FEI Number
3005180112
Address
1302 Wrights Ln E, West Chester, Pennsylvania 19380, United States
Country
United States
ID: 9d52931c-933d-4c92-bcf8-3d7b3bc2d279