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FDA Inspection
•Amo Groningen BV•April 22, 2010

Amo Groningen BV – FDA Inspection, Apr 22, 2010

Record Details

This FDA Inspection record concerns Amo Groningen BV, with an inspection on April 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company
Amo Groningen BV
Inspection Date
April 22, 2010
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · cc1ceb37-f2ca-44c6-bd1b-4298a390cea1

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
663960
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.100(a)(1)Analysis of data sources
  2. 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
  3. 21 CFR 820.100(a)(1)Procedure for analysis of data sources

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Amo Groningen BV

2
DateClassificationOfficeProject area
November 13, 2019VAICenter for Devices and Radiological HealthCompliance: Devices
February 13, 2014VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Amo Groningen BV
  • FDA Inspection 1111640 - 2019-11-13
  • FDA Inspection 870154 - 2014-02-13

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