HAELSSEN & LYON NORTH AMERICA CO FDA Record

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

  • Latest inspection NAI · Apr 9, 2025
  • No warning letters matched by name
Inspections 2 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

HAELSSEN & LYON NORTH AMERICA CO has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "HAELSSEN & LYON NORTH AMERICA CO" is on file.

What these totals cover: FDA records filed under the name "HAELSSEN & LYON NORTH AMERICA CO" and its spelling variant "Haelssen And Lyon North America".

Latest inspection
Apr 9, 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

HAELSSEN & LYON NORTH AMERICA CO's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

HAELSSEN & LYON NORTH AMERICA CO: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
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

2 inspections from Aug 21, 2018 to Apr 9, 2025.

DateSiteProductClassificationFEI
Apr 9, 2025Westport, CTFood/CosmeticsNo Action Indicated (NAI)3017714117
Aug 21, 2018New York, NYFood/CosmeticsNo Action Indicated (NAI)3013064152
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3017714117Westport, CT1Apr 9, 2025
FEI 3013064152New York, NY1Aug 21, 2018

HAELSSEN & LYON NORTH AMERICA CO and the FDA: common questions

Has HAELSSEN & LYON NORTH AMERICA CO received an FDA warning letter?

No FDA warning letter addressed to the name "HAELSSEN & LYON NORTH AMERICA CO" 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 HAELSSEN & LYON NORTH AMERICA CO received an FDA Form 483?

FDA has not published a Form 483 for "HAELSSEN & LYON NORTH AMERICA CO" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect HAELSSEN & LYON NORTH AMERICA CO?

The most recent FDA inspection on file ended Apr 9, 2025 at Westport, CT and was classified NAI. FDA has 2 inspections of HAELSSEN & LYON NORTH AMERICA CO on file.

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