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FDA Inspection
•MiE medical imaging electronics GmbH•May 31, 2018

MiE medical imaging electronics GmbH – FDA Inspection, May 31, 2018

Record Details

This FDA Inspection record concerns MiE medical imaging electronics GmbH, with an inspection on May 31, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
MiE medical imaging electronics GmbH
Inspection Date
May 31, 2018
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Ronald Ifraimov (Company Rep)
View Company Profile

ID · 6a92dea0-3c05-4ff4-ac9a-ea2a5d313179

Inspection Facts

Inspection number
1053692
FDA center
Medical Devices & Rad Health
Project area
Radiation Control and Health Safety Act
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.184DHR - not or inadequately maintained
  2. 21 CFR 820.198(a)Complaints
  3. 21 CFR 820.50(a)(1)Documented evaluation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of MiE medical imaging electronics GmbH

1
DateClassificationOfficeProject area
October 12, 2023Not classifiedOffice of Inspections and Investigations
Other documents for MiE medical imaging electronics GmbH
  • FDA Inspection 1220602 - 2023-10-12

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