Company
United StatesSynthes (USA) Products LLC, West Chester, PA – FDA Inspections
Inspection records and compliance data for Synthes (USA) Products LLC in West Chester, Pennsylvania. 7 FDA inspections on record, 2 Form 483s, last inspected October 20, 2017.
Company Profile
This profile covers Synthes (USA) Products LLC based in West Chester, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 2
- Warning letters
- 0
First inspected April 20, 2009. Last inspected October 20, 2017.
Most cited issue areas
- Quality Audits - defined intervals1 inspection
- Reporting Information Reasonably Known1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 20, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1029323 |
| October 17, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1032557 |
| October 13, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1028729 |
| September 25, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1083832 |
| October 29, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 695834 |
| April 27, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 583439 |
| April 20, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 585143 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Synthes (USA) Products LLC
FEI Number
3008812560
Address
1301 Goshen Pkwy, West Chester, Pennsylvania 19380, United States
Country
United States
ID: f18ef1d0-de31-48cb-afdf-ad711cbff58f