COSMED Nordic ApS – FDA Inspection, Feb 16, 2012

Record Details

This FDA Inspection record concerns COSMED Nordic ApS, with an inspection on February 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: COSMED Nordic ApS
Inspection Date: February 16, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · c359daaf-1439-480c-a210-3359b8a6d53f

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 772945
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.198(a)Complaints
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.198(b)Review and evaluation for investigation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.198(b)Rationale documented for no investigation
21 CFR 820.40(b)Change records, content
21 CFR 820.200(d)Service reports
21 CFR 820.184DHR content

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of COSMED Nordic ApS

Date	Classification	Office	Project area
October 26, 2022	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 24, 2017	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 12, 2013	NAI	Center for Devices and Radiological Health	Compliance: Devices