Company
United StatesSynthes (USA), LLC, Monument, CO – FDA Inspections
Inspection records and compliance data for Synthes (USA), LLC in Monument, Colorado. 4 FDA inspections on record, last inspected January 18, 2017.
Company Profile
This profile covers Synthes (USA), LLC based in Monument, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected February 25, 2009. Last inspected January 18, 2017.
Most cited issue areas
- CAPA verification/validation of corrective/preventive action1 inspection
- Lack of or inadequate process validation1 inspection
- Review of data and documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 18, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 999208 |
| May 8, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 926215 |
| February 1, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 765879 |
| February 25, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 565017 |
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
Synthes (USA), LLC
FEI Number
1719045
Address
1101 Synthes Ave, Monument, Colorado 80132, United States
Country
United States
ID: bf9137e7-3e57-4dcd-97cf-de0494f0c7cc