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Cilag AG

FDA Regulatory Profile

Cilag AG has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Cilag AG" and its spelling variant "Cilag". Records filed under related names are not included; see Related names.

Latest inspection
Nov 21, 2025 · NAI

Newer recall under related name Ethicon: Sep 23, 2026, Z-0284-2027.

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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
Inspections8Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA Record by Year

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

Cilag AG: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202310000
202200000
202100000
202000000
201910000
201800000
201700000

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

8 inspections from May 15, 2009 to Nov 21, 2025.

DateSiteProductClassificationFEI
Nov 21, 2025Schaffhausen, SwitzerlandDrugsNo Action Indicated (NAI)3002806695
May 5, 2023Schaffhausen, SwitzerlandDrugsNo Action Indicated (NAI)3002806695
Jul 16, 2019Schaffhausen, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002806695
Sep 8, 2015Schaffhausen, SwitzerlandDrugsNo Action Indicated (NAI)3002806695
Feb 18, 2014Schaffhausen, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002806695
Apr 27, 2012Schaffhausen, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002806695
Jun 3, 2010Schaffhausen, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002806695
May 15, 2009Schaffhausen, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002806695

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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002806695Schaffhausen, Switzerland8Nov 21, 2025

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FDA data resources

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