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QPharma AB

FDA Regulatory Profile

QPharma AB has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "QPharma AB" and its spelling variant "Qpharma".

Latest inspection
May 6, 2025 · 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
Inspections7Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

QPharma AB: FDA inspections per year 2017: 2 inspections220172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 2 inspections220232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202320000
202200000
202100000
202000000
201900000
201800000
201720000

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

7 inspections from Mar 27, 2014 to May 6, 2025.

DateSiteProductClassificationFEI
May 6, 2025Cedar Knolls, NJBiologicsNo Action Indicated (NAI)3008626682
May 12, 2023Malmo, SwedenDrugsVoluntary Action Indicated (VAI)3004620701
Mar 31, 2023Malmo, SwedenDrugsNo Action Indicated (NAI)3004620701
Nov 23, 2017Malmo, SwedenDrugsVoluntary Action Indicated (VAI)3004620701
Sep 26, 2017Cedar Knolls, NJDrugsNo Action Indicated (NAI)3008626682
Jun 1, 2016Malmo, SwedenDrugsNo Action Indicated (NAI)3004620701
Mar 27, 2014Malmo, SwedenDrugsVoluntary Action Indicated (VAI)3004620701
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 3008626682Cedar Knolls, NJ2May 6, 2025
FEI 3004620701Malmo, Sweden5May 12, 2023

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FDA data resources

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