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FDA Inspection
•KONINKLIJKE (ROYAL) UTERMOHLEN N.V.•November 29, 2018

KONINKLIJKE (ROYAL) UTERMOHLEN N.V. – FDA Inspection, Nov 29, 2018

Record Details

This FDA Inspection record concerns KONINKLIJKE (ROYAL) UTERMOHLEN N.V., with an inspection on November 29, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
KONINKLIJKE (ROYAL) UTERMOHLEN N.V.
Inspection Date
November 29, 2018
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Andrew J. Garufi (Issuing Officer)
View Company Profile

ID · f9268db0-bd61-4c6d-82ce-33cd43495a8a

Inspection Facts

Inspection number
1073246
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.40(a)Document review, approval documentation
  3. 21 CFR 820.80(e)Documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of KONINKLIJKE (ROYAL) UTERMOHLEN N.V.

1
DateClassificationOfficeProject area
June 18, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for KONINKLIJKE (ROYAL) UTERMOHLEN N.V.
  • FDA Inspection 933698 - 2015-06-18

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