FDA Inspection
ETI GmbH Ingenieurburo fur MedizintechnikETI GmbH Ingenieurburo fur Medizintechnik – FDA Inspection, Apr 19, 2018
Record Details
This FDA Inspection record concerns ETI GmbH Ingenieurburo fur Medizintechnik, with an inspection on April 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 93e56172-9bd4-4e86-8552-5e32d00a5fad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049540
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.180(b)Retention period
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