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Sicor Societa' Italiana Corticosteroidi S.R.L. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Jul 7, 2023
No warning letters matched by name

Inspections 16

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Sicor Societa' Italiana Corticosteroidi S.R.L. has 0 FDA recalls, 16 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sicor Societa' Italiana Corticosteroidi S.R.L." is on file.

What these totals cover: FDA records filed under the name "Sicor Societa' Italiana Corticosteroidi S.R.L." and its spelling variant "Sicor Societa' Italiana Corticosteroidi".

Latest inspection: Jul 7, 2023 · VAI

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	16	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Sicor Societa' Italiana Corticosteroidi S.R.L.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Sicor Societa' Italiana Corticosteroidi S.R.L.: FDA inspections per year

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	1	0	0	0	0
2022	2	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	2	0	0	0	0
2018	1	0	0	0	0
2017	1	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.

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Recent FDA inspections

16 inspections from Aug 5, 2009 to Jul 7, 2023.

Date	Site	Product	Classification	FEI
Jul 7, 2023	Caronno Pertusella, Italy	Drugs	Voluntary Action Indicated (VAI)	3003726937
Aug 5, 2022	Villanterio, Italy	Drugs	Voluntary Action Indicated (VAI)	3002807941
Apr 15, 2022	Santhia, Italy	Drugs	Voluntary Action Indicated (VAI)	3002808100
Sep 12, 2019	Caronno Pertusella, Italy	Drugs	No Action Indicated (NAI)	3003726937
Feb 21, 2019	Villanterio, Italy	Drugs	Voluntary Action Indicated (VAI)	3002807941
Dec 21, 2018	Santhia, Italy	Drugs	Voluntary Action Indicated (VAI)	3002808100
Sep 15, 2017	Santhia, Italy	Drugs	Voluntary Action Indicated (VAI)	3002808100
Mar 4, 2016	Caronno Pertusella, Italy	Drugs	Voluntary Action Indicated (VAI)	3003726937
Jan 22, 2016	Santhia, Italy	Drugs	Voluntary Action Indicated (VAI)	3002808100
Sep 24, 2015	Villanterio, Italy	Drugs	No Action Indicated (NAI)	3002807941
Dec 12, 2012	Santhia, Italy	Drugs	Voluntary Action Indicated (VAI)	3002808100
Nov 29, 2012	Caronno Pertusella, Italy	Drugs	No Action Indicated (NAI)	3003726937
Sep 28, 2012	Villanterio, Italy	Drugs	Voluntary Action Indicated (VAI)	3002807941
Mar 22, 2012	Settimo Milanese, Italy	Drugs	No Action Indicated (NAI)	3002807245
Dec 16, 2010	Santhia, Italy	Drugs	No Action Indicated (NAI)	3002808100
Aug 5, 2009	Caronno Pertusella, Italy	Drugs	No Action Indicated (NAI)	3003726937

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

4 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003726937	Caronno Pertusella, Italy	5	Jul 7, 2023
FEI 3002807941	Villanterio, Italy	4	Aug 5, 2022
FEI 3002808100	Santhia, Italy	6	Apr 15, 2022
FEI 3002807245	Settimo Milanese, Italy	1	Mar 22, 2012

Sicor Societa' Italiana Corticosteroidi S.R.L. and the FDA: common questions

Has Sicor Societa' Italiana Corticosteroidi S.R.L. received an FDA warning letter?

No FDA warning letter addressed to the name "Sicor Societa' Italiana Corticosteroidi S.R.L." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Sicor Societa' Italiana Corticosteroidi S.R.L. received an FDA Form 483?

FDA has not published a Form 483 for "Sicor Societa' Italiana Corticosteroidi S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sicor Societa' Italiana Corticosteroidi S.R.L.?

The most recent FDA inspection on file ended Jul 7, 2023 at Caronno Pertusella, Italy and was classified VAI. FDA has 16 inspections of Sicor Societa' Italiana Corticosteroidi S.R.L. on file.

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