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FDA Inspection
•OD-OS GmbH•November 30, 2017

OD-OS GmbH – FDA Inspection, Nov 30, 2017

Record Details

This FDA Inspection record concerns OD-OS GmbH, with an inspection on November 30, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
OD-OS GmbH
Inspection Date
November 30, 2017
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Stanley B. Eugene (Company Rep)
View Company Profile

ID · a041df4a-3ccf-4c86-9fa5-e52db0b0291d

Inspection Facts

Inspection number
1036165
FDA center
Medical Devices & Rad Health
Project area
Radiation Control and Health Safety Act
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.30(f)Design verification - documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of OD-OS GmbH

3
DateClassificationOfficeProject area
May 21, 2026Not classifiedOffice of Inspections and Investigations
November 29, 2023NAICenter for Devices and Radiological HealthCompliance: Devices
January 29, 2015VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for OD-OS GmbH
  • FDA Inspection 1323728 - 2026-05-21
  • FDA Inspection 1225993 - 2023-11-29
  • FDA Inspection 914693 - 2015-01-29

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