FDA Inspection
SMT Schilling Metalltechnik GmbHSMT Schilling Metalltechnik GmbH – FDA Inspection, Apr 6, 2017
Record Details
This FDA Inspection record concerns SMT Schilling Metalltechnik GmbH, with an inspection on April 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · 7ec42291-5837-469c-a71f-6d93c284c6c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010329
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
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Other FDA inspections of SMT Schilling Metalltechnik GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 14, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 2, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 19, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SMT Schilling Metalltechnik GmbH
- FDA Inspection 1198277 - 2023-01-26
- FDA Inspection 1109766 - 2019-11-14
- FDA Inspection 923692 - 2015-04-02
- FDA Inspection 792579 - 2012-07-19
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