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Advanced Accelerator Applications (Italy) S.R.L.

FDA Regulatory Profile

Advanced Accelerator Applications (Italy) S.R.L. 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 "Advanced Accelerator Applications (Italy) S.R.L." and its spelling variant "Advanced Accelerator Applications (Italy)". Records filed under related names are not included; see Related names.

Latest inspection: Oct 13, 2023 · VAI

Newer recall under related name Novartis Pharmaceuticals Corporation: Aug 4, 2026, D-0746-2026.

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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	8	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Advanced Accelerator Applications (Italy) S.R.L.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	2	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	2	0	0	0	0
2017	0	0	0	0	0

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.

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 Advanced Accelerator Applications (Italy) S.R.L. above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Novartis Pharmaceuticals Corporation Combines 2 spellings Novartis Pharmaceuticals: 26 recalls, 13 inspections Novartis Pharmaceuticals Corporation: 7 recalls, 41 inspections	Same company group	33	0	54	0	Aug 4, 2026 (D-0746-2026)
Advanced Accelerator Applications Usa	Same company group	4	0	5	0	Sep 23, 2024 (D-0007-2025)
Sandoz Incorporated	Same company group	16	0	8	1	Apr 6, 2018 (D-0631-2018)
Sandoz Nutrition	Same company group	0	20	0	0	—
Novartis Pharma	Same company group	0	0	13	1	—
Novartis Pharma Stein	Same company group	0	0	12	0	—
Novartis	Same company group	0	0	9	0	—
Novartis Gene Therapies	Same company group	0	0	3	0	—
Novartis Innovative Technologies	Same company group	0	0	1	0	—

Recent FDA inspections

8 inspections from Oct 13, 2015 to Oct 13, 2023.

Date	Site	Product	Classification	FEI
Oct 13, 2023	Colleretto Giacosa, Italy	Drugs	Voluntary Action Indicated (VAI)	3010175147
Mar 3, 2023	Saluggia, Italy	Drugs	Voluntary Action Indicated (VAI)	3009551251
Sep 3, 2019	Colleretto Giacosa, Italy	Drugs	Voluntary Action Indicated (VAI)	3010175147
Oct 26, 2018	Saluggia, Italy	Drugs	Voluntary Action Indicated (VAI)	3009551251
Jun 8, 2018	Saluggia, Italy	Drugs	Voluntary Action Indicated (VAI)	3009551251
Aug 12, 2016	Meldola, Italy	Drugs	Voluntary Action Indicated (VAI)	3010469290
Aug 5, 2016	Colleretto Giacosa, Italy	Drugs	Voluntary Action Indicated (VAI)	3010175147
Oct 13, 2015	Saluggia, Italy	Drugs	Voluntary Action Indicated (VAI)	3009551251

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.

Facility	Location	Inspections	Latest
FEI 3010175147	Colleretto Giacosa, Italy	3	Oct 13, 2023
FEI 3009551251	Saluggia, Italy	4	Mar 3, 2023
FEI 3010469290	Meldola, Italy	1	Aug 12, 2016

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