American Cruise Lines Inc/ American Independence FDA Record

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

  • Latest inspection NAI · Jan 24, 2025
  • No warning letters matched by name
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

American Cruise Lines Inc/ American Independence has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "American Cruise Lines Inc/ American Independence" is on file.

What these totals cover: FDA records filed under the name "American Cruise Lines Inc/ American Independence".

Latest inspection
Jan 24, 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
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

American Cruise Lines Inc/ American Independence: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202311000
202200000
202100000
202000000
201900000
201800000
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

2 inspections from Sep 21, 2023 to Jan 24, 2025.

DateSiteProductClassificationFEI
Jan 24, 2025Guilford, CTFood/CosmeticsNo Action Indicated (NAI)3016965794
Sep 21, 2023Guilford, CTFood/CosmeticsOfficial Action Indicated (OAI)3016965794
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 3016965794Guilford, CT2Jan 24, 2025

American Cruise Lines Inc/ American Independence and the FDA: common questions

Has American Cruise Lines Inc/ American Independence received an FDA warning letter?

No FDA warning letter addressed to the name "American Cruise Lines Inc/ American Independence" 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 American Cruise Lines Inc/ American Independence received an FDA Form 483?

FDA has not published a Form 483 for "American Cruise Lines Inc/ American Independence" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect American Cruise Lines Inc/ American Independence?

The most recent FDA inspection on file ended Jan 24, 2025 at Guilford, CT and was classified NAI. FDA has 2 inspections of American Cruise Lines Inc/ American Independence 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.