Domino S.R.L. FDA Record

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

Domino S.R.L. has 0 FDA recalls, 6 inspections, 2 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Domino S.R.L., the most recent on Jan 19, 2017.

What these totals cover: FDA records filed under the name "Domino S.R.L." and its spelling variant "Domino".

Latest inspection
Sep 23, 2025 · NAI
Latest 510(k)
Sep 21, 2007

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Domino S.R.L.: FDA inspections per year 2017: 2 inspections220172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 1 inspections120242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202410000
202300000
202200000
202100000
202000000
201900000
201800000
201720100

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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Domino S.R.L. FDA Warning Letters

1 warning letter on Jan 19, 2017.

IssuedSubjectIssuing officeClose-out letter
Jan 19, 2017

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

6 inspections from May 26, 2010 to Sep 23, 2025.

DateSiteProductClassificationFEI
Sep 23, 2025Saint Peters, MOFood/CosmeticsNo Action Indicated (NAI)3004305284
Dec 19, 2024Codogne', ItalyDevicesNo Action Indicated (NAI)3006153348
Sep 14, 2017Codogne', ItalyDevicesVoluntary Action Indicated (VAI)3006153348
Mar 8, 2017Saint Peters, MOFood/CosmeticsNo Action Indicated (NAI)3004305284
Jun 5, 2014Codogne', ItalyDevicesVoluntary Action Indicated (VAI)3006153348
May 26, 2010Saint Peters, MOFood/CosmeticsNo Action Indicated (NAI)3004305284
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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Domino S.R.L.: warning letters, injunctions and seizures. It came from FDA's Center for Tobacco Products, which regulates tobacco retailers and manufacturers. It is not a drug, medical device or food manufacturing action.

Most recent: Warning Letter, Jan 19, 2017.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004305284Saint Peters, MO3Sep 23, 2025
FEI 3006153348Codogne', Italy3Dec 19, 2024

Recent 510(k) clearances

2 510(k) clearances from Apr 30, 2007 to Sep 21, 2007.

K-NumberDeviceDate
K071431GLOBUS GENESY 1100 STIMULATORSep 21, 2007
K061632GLOBUS PREMIUM MUSCLE STIMULATORApr 30, 2007

Domino S.R.L. and the FDA: common questions

Has Domino S.R.L. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Domino S.R.L.. The most recent is dated Jan 19, 2017.

Has Domino S.R.L. received an FDA Form 483?

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

When did the FDA last inspect Domino S.R.L.?

The most recent FDA inspection on file ended Sep 23, 2025 at Saint Peters, MO and was classified NAI. FDA has 6 inspections of Domino S.R.L. on file.

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