FDA Inspection
SMT Schilling Metalltechnik GmbHSMT Schilling Metalltechnik GmbH – FDA Inspection, Jul 19, 2012
Record Details
This FDA Inspection record concerns SMT Schilling Metalltechnik GmbH, with an inspection on July 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 19, 2012
- Product Type
- Devices
View Company Profile
ID · 334067a4-0be7-4bfb-8224-7428524f4cba
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 792579
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Showing 10 of 12 citations.
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 |
| November 14, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 |
Other documents for SMT Schilling Metalltechnik GmbH
- FDA Inspection 1198277 - 2023-01-26
- FDA Inspection 1109766 - 2019-11-14
- FDA Inspection 1010329 - 2017-04-06
- FDA Inspection 923692 - 2015-04-02
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.