FDA inspection

Agfa Gevaert NV: FDA inspection ending Feb 18, 2016

FDA inspection 966676 · Mortsel

Key facts

Inspection ID	966676
Firm	Agfa Gevaert NV
FEI number	3002809633
Address	Septestraat 27
City	Mortsel
Fiscal year	2016
Inspection end date	Feb 18, 2016
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\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority
Product type	Devices

At a glance

None Citations
None 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.

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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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