FDA Inspection
SMT Schilling Metalltechnik GmbHSMT Schilling Metalltechnik GmbH – FDA Inspection, Nov 14, 2019
Record Details
This FDA Inspection record concerns SMT Schilling Metalltechnik GmbH, with an inspection on November 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 14, 2019
- Product Type
- Devices
View Company Profile
ID · 8b61dd9c-8741-4357-bff5-d1b852b8fbcc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109766
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| April 6, 2017 | VAI | Center for Devices and Radiological Health | Compliance: 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 1010329 - 2017-04-06
- FDA Inspection 923692 - 2015-04-02
- FDA Inspection 792579 - 2012-07-19
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.