Aquanova AG FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Aquanova AG has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Aquanova AG" is on file.

What these totals cover: FDA records filed under the name "Aquanova AG" and its spelling variant "Aquanova".

Latest inspection
Feb 14, 2014 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections from Feb 11, 2013 to Feb 14, 2014.

DateSiteProductClassificationFEI
Feb 14, 2014Tumbes, PeruFood/CosmeticsVoluntary Action Indicated (VAI)2000031612
Feb 11, 2013Darmstadt, GermanyFood/CosmeticsNo Action Indicated (NAI)3003641717
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.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 2000031612Tumbes, Peru1Feb 14, 2014
FEI 3003641717Darmstadt, Germany1Feb 11, 2013

Aquanova AG and the FDA: common questions

Has Aquanova AG received an FDA warning letter?

No FDA warning letter addressed to the name "Aquanova AG" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Aquanova AG received an FDA Form 483?

FDA has not published a Form 483 for "Aquanova AG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Aquanova AG?

The most recent FDA inspection on file ended Feb 14, 2014 at Tumbes, Peru and was classified VAI. FDA has 2 inspections of Aquanova AG on file.

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