Milos Inc. FDA Record

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

Milos Inc. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Milos Inc., the most recent on Oct 4, 2017.

What these totals cover: FDA records filed under the name "Milos Inc." and its spelling variant "Milos".

Latest inspection
Apr 14, 2025 · NAI

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 actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Milos Inc.: FDA inspections per year 2017: 1 inspections120172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 1 inspections120222023: 1 inspections120232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202310000
202210000
202110000
202000000
201900000
201810000
201711100

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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Milos Inc. FDA Warning Letters

1 warning letter on Oct 4, 2017.

IssuedSubjectIssuing officeClose-out letter
Oct 4, 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 Apr 28, 2017 to Apr 14, 2025.

DateSiteProductClassificationFEI
Apr 14, 2025New York, NYFood/CosmeticsNo Action Indicated (NAI)3002320950
Aug 11, 2023New York, NYFood/CosmeticsNo Action Indicated (NAI)3002320950
Jun 27, 2022New York, NYFood/CosmeticsVoluntary Action Indicated (VAI)3002320950
Apr 30, 2021New York, NYFood/CosmeticsVoluntary Action Indicated (VAI)3002320950
Mar 26, 2018New York, NYFood/CosmeticsNo Action Indicated (NAI)3002320950
Apr 28, 2017New York, NYFood/CosmeticsOfficial Action Indicated (OAI)3002320950
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 Milos Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 4, 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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002320950New York, NY6Apr 14, 2025

Milos Inc. and the FDA: common questions

Has Milos Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Milos Inc.. The most recent is dated Oct 4, 2017.

Has Milos Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Milos Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Milos Inc.?

The most recent FDA inspection on file ended Apr 14, 2025 at New York, NY and was classified NAI. FDA has 6 inspections of Milos Inc. on file, 1 of them classified OAI (official action indicated).

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