Atlantic U.S.A. Inc.

FDA Regulatory Profile

Atlantic U.S.A. Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 12, 2025 · NAI

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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
Inspections3Nov 12, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA Record by Year

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

Atlantic U.S.A. Inc.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202110000
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.

Recent FDA Inspections

DateSiteProductClassificationFEI
May 12, 2025New York, NYFood/CosmeticsNo Action Indicated (NAI)1000190743
Mar 2, 2021New York, NYFood/CosmeticsNo Action Indicated (NAI)1000190743
Aug 30, 2018New York, NYFood/CosmeticsVoluntary Action Indicated (VAI)1000190743

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means 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

FacilityLocationInspectionsLatest
FEI 1000190743New York, NY3May 12, 2025

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