Company
GermanySynthes Tuttlingen GmbH, Tuttlingen, Germany – FDA Inspections
Inspection records and compliance data for Synthes Tuttlingen GmbH in Tuttlingen. 2 FDA inspections on record, 1 Form 483, last inspected August 02, 2018.
Company Profile
This profile covers Synthes Tuttlingen GmbH based in Tuttlingen, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 7, 2013. Last inspected August 2, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2018 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1060885 |
| November 7, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 853842 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Synthes Tuttlingen GmbH
FEI Number
3004186932
Address
Unter Haslen 5, Tuttlingen, Germany
Country
Germany
ID: 8e5a5146-dec8-4154-a8bf-8533b2602874