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Loxo Oncology, Inc.

FDA Regulatory Profile

Loxo Oncology, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Loxo Oncology, Inc." and its spelling variant "Loxo Oncology". They do not include records filed under Eli Lilly And or other names in its corporate family; those are listed under Related names, each with its own counts.

Latest inspection
Sep 15, 2023 · NAI

Newer recall under related name Eli Lilly And: Mar 12, 2024, D-0445-2024.

Part of the Eli Lilly And corporate family.

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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
Inspections3Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Loxo Oncology, Inc.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202210000
202100000
202000000
201900000
201810000
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

3 inspections from May 2, 2018 to Sep 15, 2023.

DateSiteProductClassificationFEI
Sep 15, 2023Stamford, CTDrugsNo Action Indicated (NAI)3013708698
Sep 9, 2022South San Francisco, CADrugsNo Action Indicated (NAI)3021192612
May 2, 2018South San Francisco, CADrugsNo Action Indicated (NAI)3013762695
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 3013708698Stamford, CT1Sep 15, 2023
FEI 3021192612South San Francisco, CA1Sep 9, 2022
FEI 3013762695South San Francisco, CA1May 2, 2018

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FDA data resources

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