Company
GermanyRudischhauser Surgical Instruments Manufacturing GmbH, Tuttlingen, Germany – FDA Inspections
Inspection records and compliance data for Rudischhauser Surgical Instruments Manufacturing GmbH in Tuttlingen. 3 FDA inspections on record, 1 Form 483, last inspected September 21, 2022.
Company Profile
This profile covers Rudischhauser Surgical Instruments Manufacturing GmbH based in Tuttlingen, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 4, 2013. Last inspected September 21, 2022.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- DHR content1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 21, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1180922 |
| December 8, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 995720 |
| December 4, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 859239 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Rudischhauser Surgical Instruments Manufacturing GmbH
FEI Number
3008237805
Address
Gansacker 28, Tuttlingen, Germany
Country
Germany
ID: 27680674-25dd-44f0-a0df-4ac002264534