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FDA Inspection
•Nicolay GmbH•June 9, 2011

Nicolay GmbH – FDA Inspection, Jun 9, 2011

Record Details

This FDA Inspection record concerns Nicolay GmbH, with an inspection on June 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
Nicolay GmbH
Inspection Date
June 9, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 992005f8-a05e-4cf6-a6db-9814b2fa7f31

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
735618
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

1
  1. 21 CFR 820.184Lack of or inadequate DHR procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Nicolay GmbH

2
DateClassificationOfficeProject area
December 14, 2023VAICenter for Devices and Radiological HealthCompliance: Devices
March 18, 2009VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Nicolay GmbH
  • FDA Inspection 1226791 - 2023-12-14
  • FDA Inspection 574381 - 2009-03-18

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