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Eli Lilly Italia SPA

FDA Regulatory Profile

Eli Lilly Italia SPA has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

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

Latest inspection: Apr 4, 2023 · VAI

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

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Eli Lilly Italia SPA above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Eli Lilly And	Same company group	5	7	36	3	Mar 12, 2024 (D-0445-2024)
Lilly Del Caribe	Same company group	0	0	20	1	—
Lilly France	Same company group	0	0	7	0	—
Loxo Oncology	Same company group	0	0	3	0	—
Lilly Research Laboratories	Same company group	0	2	0	0	—
Imclone Systems	Same company group	0	0	1	0	—

Recent FDA inspections

1 inspection on Apr 4, 2023.

Date	Site	Product	Classification	FEI
Apr 4, 2023	Sesto Fiorentino, Italy	Drugs	Voluntary Action Indicated (VAI)	3002806895

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002806895	Sesto Fiorentino, Italy	1	Apr 4, 2023

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