FDA Inspection
IRT Systems GmbHIRT Systems GmbH – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns IRT Systems GmbH, with an inspection on June 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7e726fef-bca3-40ee-9539-bb9f263c155e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020729
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.80(e)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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