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IBA Dosimetry GmbH FDA Inspection Record

FEI 3006653576 · Inspections, Form 483s, warning letters and import refusals

IBA Dosimetry GmbH is an FDA-registered facility (FEI 3006653576) located in SCHWARZENBRUCK Bavaria, DE. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Sep 13, 2013: No Action Indicated (NAI)
Inspections on record
1 (1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
5, latest Apr 1, 2025
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 13, 2013No Action Indicated (NAI)Lack of or inadequate DHR procedures (21 CFR 820.184)
Servicing - Lack of or inadequate procedures (21 CFR 820.200(a))
Documentation (21 CFR 820.100(b))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Apr 1, 2025Class IIZ-1703-2025myQA iON; Article Number: MQ10-000;
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
Dec 10, 2015Class IIZ-0683-2016IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled…
Feb 2, 2015Class IIZ-1212-2015COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction…
Sep 25, 2014Class IIZ-0168-2015COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator)…
Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can…
Aug 20, 2013Class IIZ-0456-2014iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear…
The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI)…

FDA record score

4 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

5 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-1703-2025, this FEI as the recalling firmApr 1, 20254 x 14
Class II recall Z-0683-2016, this FEI as the recalling firmDec 10, 201510 years or older, so it adds no points0
Class II recall Z-1212-2015, this FEI as the recalling firmFeb 2, 201510 years or older, so it adds no points0
Class II recall Z-0168-2015, this FEI as the recalling firmSep 25, 201410 years or older, so it adds no points0
Class II recall Z-0456-2014, this FEI as the recalling firmAug 20, 201310 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
IBA Dosimetry GmbH
Location
SCHWARZENBRUCK Bavaria (DE)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.