FDA Inspection
I.T.S. GmbHI.T.S. GmbH – FDA Inspection, Jun 22, 2017
Record Details
This FDA Inspection record concerns I.T.S. GmbH, with an inspection on June 22, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · ae4ed3c6-c92c-4a46-b7c4-7996d23b819f
Inspection Facts
- Inspection number
- 1020730
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.80(e)Documentation
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Other FDA inspections of I.T.S. GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2023 | Not classified | Office of Inspections and Investigations | |
| January 19, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 3, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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