Company
GermanySMT Schilling Metalltechnik GmbH, Muhlheim An Der Donau, Germany – FDA Inspections
Inspection records and compliance data for SMT Schilling Metalltechnik GmbH in Muhlheim An Der Donau. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 26, 2023.
Company Profile
This profile covers SMT Schilling Metalltechnik GmbH based in Muhlheim An Der Donau, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 19, 2012. Last inspected January 26, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of Written MDR Procedures2 inspections
- Design control - no procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 26, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1198277 |
| November 14, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1109766 |
| April 6, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1010329 |
| April 2, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 923692 |
| July 19, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 792579 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SMT Schilling Metalltechnik GmbH
FEI Number
3001026312
Address
Griesweg 33, Muhlheim An Der Donau, Germany
Country
Germany
ID: 788727eb-0c3a-4bc6-ac94-d5211be4b2fc