FDA Inspection
Dimeda Instrumente GmbHDimeda Instrumente GmbH – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns Dimeda Instrumente GmbH, with an inspection on August 30, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Dimeda Instrumente GmbH
- Inspection Date
- August 30, 2018
- Product Type
- Medical Devices & Rad Health
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ID · f7d0203c-3c1c-46e2-9e7a-41d098c7aa6c
Inspection Facts
- Inspection number
- 1064785
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Dimeda Instrumente GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dimeda Instrumente GmbH
- FDA Inspection 1197575 - 2023-01-26
- FDA Inspection 702557 - 2010-12-02
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