FDA inspection

Tonica Elektronik A/S: FDA inspection ending Dec 7, 2017

FDA inspection 1036735 · Voluntary Action Indicated (VAI) · Farum

Key facts

Inspection ID	1036735
Firm	Tonica Elektronik A/S
FEI number	3005545216
Address	Lucernemarken 15
City	Farum
Fiscal year	2018
Inspection end date	Dec 7, 2017
Classification	Voluntary Action Indicated (VAI)
Project area	Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices
Product type	Devices

At a glance

None Citations
1–9 Posted citations
No Warning letter followed
Yes Form FDA 483 issued
No Establishment inspection report (EIR) exists
1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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