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Care Diagnostica GmbH

FDA Regulatory Profile

Care Diagnostica GmbH has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Care Diagnostica GmbH" and its spelling variant "Care Diagnostica".

Latest inspection: Dec 13, 2012 · OAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA inspections

1 inspection on Dec 13, 2012.

Date	Site	Product	Classification	FEI
Dec 13, 2012	Moellersdorf, Austria	Devices	Official Action Indicated (OAI)	3003591731

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Care Diagnostica GmbH: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 23, 2013.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003591731	Moellersdorf, Austria	1	Dec 13, 2012

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