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Esteve Quimica, S.A.

FDA Regulatory Profile

Esteve Quimica, S.A. has 0 FDA recalls, 21 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Esteve Quimica, S.A." and its spelling variant "Esteve Quimica".

Latest inspection
Oct 24, 2025 · VAI

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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
Inspections21Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Esteve Quimica, S.A.: FDA inspections per year 2017: 2 inspections220172018: 3 inspections320182019: 1 inspections120192020: 0 inspections020202021: 2 inspections220212022: 0 inspections020222023: 1 inspections120232024: 1 inspections120242025: 2 inspections220252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202520000
202410000
202310000
202200000
202120000
202000000
201911000
201830000
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

21 inspections from Jul 2, 2010 to Oct 24, 2025. Showing the 20 most recent. View all 21 inspections

DateSiteProductClassificationFEI
Oct 24, 2025Banyeres Del Penedes, SpainDrugsVoluntary Action Indicated (VAI)3006616345
Sep 18, 2025Celra, SpainDrugsVoluntary Action Indicated (VAI)3002806937
Oct 17, 2024Llica De Vall, SpainDrugsVoluntary Action Indicated (VAI)3002808427
Mar 17, 2023Llica De Vall, SpainDrugsVoluntary Action Indicated (VAI)3002808427
Sep 23, 2021Celra, SpainDrugsVoluntary Action Indicated (VAI)3002806937
Sep 20, 2021Banyeres Del Penedes, SpainDrugsVoluntary Action Indicated (VAI)3006616345
Sep 5, 2019Llica De Vall, SpainDrugsOfficial Action Indicated (OAI)3002808427
Jun 22, 2018Banyeres Del Penedes, SpainDrugsVoluntary Action Indicated (VAI)3006616345
Jun 22, 2018Barcelona, SpainDrugsVoluntary Action Indicated (VAI)3002806936
Jun 19, 2018Celra, SpainDrugsVoluntary Action Indicated (VAI)3002806937
Jun 23, 2017Banyeres Del Penedes, SpainDrugsNo Action Indicated (NAI)3006616345
Jun 16, 2017Celra, SpainDrugsNo Action Indicated (NAI)3002806937
Apr 7, 2016Banyeres Del Penedes, SpainDrugsNo Action Indicated (NAI)3006616345
Sep 18, 2015Llica De Vall, SpainDrugsNo Action Indicated (NAI)3002808427
Feb 18, 2015Barcelona, SpainDrugsNo Action Indicated (NAI)3002806936
Nov 7, 2013Celra, SpainDrugsNo Action Indicated (NAI)3002806937
May 3, 2013Banyeres Del Penedes, SpainDrugsVoluntary Action Indicated (VAI)3006616345
Jul 27, 2012Llica De Vall, SpainDrugsVoluntary Action Indicated (VAI)3002808427
Jun 21, 2012Barcelona, SpainDrugsNo Action Indicated (NAI)3002806936
Jul 8, 2010Celra, SpainDrugsVoluntary Action Indicated (VAI)3002806937
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

4 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3006616345Banyeres Del Penedes, Spain7Oct 24, 2025
FEI 3002806937Celra, Spain6Sep 18, 2025
FEI 3002808427Llica De Vall, Spain5Oct 17, 2024
FEI 3002806936Barcelona, Spain3Jun 22, 2018

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FDA data resources

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