Lonza, Inc.

FDA Regulatory Profile

Lonza, Inc. has 0 FDA recalls, 11 inspections, 1 510(k) clearance and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Lonza, Inc." and its spelling variants "Lonza", "Lonza Co". Records filed under related names are not included; see Related names.

Latest inspection
Jul 10, 2024 · VAI
Latest 510(k)
May 12, 1994

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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) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections11Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Lonza, Inc.: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 2 inspections220232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202320000
202210000
202100000
202000000
201900000
201800000
201710000

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

11 inspections from Jun 24, 2010 to Jul 10, 2024.

DateSiteProductClassificationFEI
Jul 10, 2024Basel Town, SwitzerlandDrugsVoluntary Action Indicated (VAI)3014753648
Dec 7, 2023Sagamihara, JapanFood/CosmeticsNo Action Indicated (NAI)3009041625
Mar 28, 2023Visp, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002930340
Nov 4, 2022Basel Town, SwitzerlandDrugsNo Action Indicated (NAI)3014753648
Dec 15, 2017Visp, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002930340
Mar 11, 2016Visp, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002930340
Aug 29, 2014Visp, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002930340
Apr 2, 2014Visp, SwitzerlandFood/CosmeticsNo Action Indicated (NAI)3002930340
Apr 12, 2013Visp, SwitzerlandDrugsNo Action Indicated (NAI)3002930340
Sep 18, 2012Visp, SwitzerlandDrugsNo Action Indicated (NAI)3002930340
Jun 24, 2010Visp, SwitzerlandDrugsVoluntary Action Indicated (VAI)3002930340
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3014753648Basel Town, Switzerland2Jul 10, 2024
FEI 3009041625Sagamihara, Japan1Dec 7, 2023
FEI 3002930340Visp, Switzerland8Mar 28, 2023

Recent 510(k) clearances

1 510(k) clearance on May 12, 1994.

K-NumberDeviceDate
K932502LONZA FORMULATION R-82May 12, 1994

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