Bioniq Health Tech Solutions, Ltd FDA Record

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

Bioniq Health Tech Solutions, Ltd has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bioniq Health Tech Solutions, Ltd" is on file.

What these totals cover: FDA records filed under the name "Bioniq Health Tech Solutions, Ltd" and its spelling variant "Bioniq Health Tech Solutions".

Latest inspection
Oct 29, 2025 · 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
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Oct 29, 2025.

DateSiteProductClassificationFEI
Oct 29, 2025London, United KingdomFood/CosmeticsVoluntary Action Indicated (VAI)3018125759
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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3018125759London, United Kingdom1Oct 29, 2025

Bioniq Health Tech Solutions, Ltd and the FDA: common questions

Has Bioniq Health Tech Solutions, Ltd received an FDA warning letter?

No FDA warning letter addressed to the name "Bioniq Health Tech Solutions, Ltd" 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 Bioniq Health Tech Solutions, Ltd received an FDA Form 483?

FDA has not published a Form 483 for "Bioniq Health Tech Solutions, Ltd" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Bioniq Health Tech Solutions, Ltd?

The most recent FDA inspection on file ended Oct 29, 2025 at London, United Kingdom and was classified VAI. FDA has 1 inspection of Bioniq Health Tech Solutions, Ltd on file.

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