QLRAD

FDA Regulatory Profile

QLRAD has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Aug 27, 2026 · NAI

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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 12, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA Record by Year

QLRAD's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

QLRAD: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202500000
202400000
202310000
202200000
202100000
202000000
201900000
201800000
201700100

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 27, 2026Almere, NetherlandsDevicesNo Action Indicated (NAI)3006948745
Jul 20, 2023Miami, FLDevicesNo Action Indicated (NAI)3010472281

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means 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

FacilityLocationInspectionsLatest
FEI 3006948745Almere, Netherlands1Aug 27, 2026
FEI 3010472281Miami, FL1Jul 20, 2023

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