Heinz Kurz GmbH Medizintechnik – FDA Inspection, Aug 3, 2017

Record Details

This FDA Inspection record concerns Heinz Kurz GmbH Medizintechnik, with an inspection on August 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Heinz Kurz GmbH Medizintechnik
Inspection Date: August 3, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Thomas E. Friel (FDA Associated Person)

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ID · db6e6f0d-3f45-435b-b97d-fd2d0d9a786c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1020733
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.70(i)Documentation of software validation

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FDA Inspection

Heinz Kurz GmbH MedizintechnikAugust 3, 2017