AMSA (Anonima Materie Sintetiche & Affini) S.P.A. FDA Record

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

  • Latest inspection VAI · May 9, 2025
  • No warning letters matched by name
Inspections 6 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

AMSA (Anonima Materie Sintetiche & Affini) S.P.A. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "AMSA (Anonima Materie Sintetiche & Affini) S.P.A." is on file.

What these totals cover: FDA records filed under the name "AMSA (Anonima Materie Sintetiche & Affini) S.P.A." and its spelling variant "Amsa (Anonima Materie Sintetiche And Affini)".

Latest inspection
May 9, 2025 · VAI

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
Inspections6Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

AMSA (Anonima Materie Sintetiche & Affini) S.P.A.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

AMSA (Anonima Materie Sintetiche & Affini) S.P.A.: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
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.

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Recent FDA inspections

6 inspections from Jul 17, 2009 to May 9, 2025.

DateSiteProductClassificationFEI
May 9, 2025Como, ItalyDrugsVoluntary Action Indicated (VAI)3002806433
Sep 2, 2022Como, ItalyDrugsVoluntary Action Indicated (VAI)3002806433
Apr 13, 2018Como, ItalyDrugsVoluntary Action Indicated (VAI)3002806433
Feb 20, 2015Como, ItalyVeterinaryNo Action Indicated (NAI)3002806433
Mar 22, 2013Como, ItalyVeterinaryNo Action Indicated (NAI)3002806433
Jul 17, 2009Como, ItalyVeterinaryVoluntary Action Indicated (VAI)3002806433
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.

FacilityLocationInspectionsLatest
FEI 3002806433Como, Italy6May 9, 2025

AMSA (Anonima Materie Sintetiche & Affini) S.P.A. and the FDA: common questions

Has AMSA (Anonima Materie Sintetiche & Affini) S.P.A. received an FDA warning letter?

No FDA warning letter addressed to the name "AMSA (Anonima Materie Sintetiche & Affini) S.P.A." 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 AMSA (Anonima Materie Sintetiche & Affini) S.P.A. received an FDA Form 483?

FDA has not published a Form 483 for "AMSA (Anonima Materie Sintetiche & Affini) S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect AMSA (Anonima Materie Sintetiche & Affini) S.P.A.?

The most recent FDA inspection on file ended May 9, 2025 at Como, Italy and was classified VAI. FDA has 6 inspections of AMSA (Anonima Materie Sintetiche & Affini) S.P.A. on file.

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