Well Luck Co. Inc. FDA Record

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

Well Luck Co. Inc. has 0 FDA recalls, 16 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Well Luck Co. Inc., the most recent on Sep 17, 2014.

What these totals cover: FDA records filed under the name "Well Luck Co. Inc." and its spelling variants "Well Luck Co", "Well Luck Company".

Latest inspection
Mar 13, 2026 · 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
Inspections16Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Well Luck Co. Inc.: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 1 inspections120192020: 1 inspections120202021: 2 inspections220212022: 0 inspections020222023: 0 inspections020232024: 4 inspections420242025: 2 inspections220252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202520000
202440000
202300000
202200000
202120000
202010000
201910000
201800000
201710000

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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Well Luck Co. Inc. FDA Warning Letters

1 warning letter on Sep 17, 2014.

IssuedSubjectIssuing officeClose-out letter
Sep 17, 2014

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

16 inspections from May 3, 2013 to Mar 13, 2026.

DateSiteProductClassificationFEI
Mar 13, 2026Houston, TXFood/CosmeticsNo Action Indicated (NAI)1000334921
Sep 19, 2025Jersey City, NJFood/CosmeticsNo Action Indicated (NAI)2246354
Apr 17, 2025Atlanta, GAFood/CosmeticsVoluntary Action Indicated (VAI)3008869000
Dec 23, 2024Jersey City, NJFood/CosmeticsVoluntary Action Indicated (VAI)2246354
Oct 18, 2024Hayward, CAFood/CosmeticsNo Action Indicated (NAI)3011967293
Aug 21, 2024Atlanta, GAFood/CosmeticsVoluntary Action Indicated (VAI)3008869000
Jan 31, 2024Jersey City, NJFood/CosmeticsVoluntary Action Indicated (VAI)2246354
Oct 26, 2021Chicago, ILFood/CosmeticsVoluntary Action Indicated (VAI)3005344592
Apr 22, 2021Commerce, CAFood/CosmeticsNo Action Indicated (NAI)3004249953
May 6, 2020Jersey City, NJFood/CosmeticsNo Action Indicated (NAI)2246354
Dec 18, 2019Atlanta, GAFood/CosmeticsVoluntary Action Indicated (VAI)3008869000
Aug 17, 2017Jersey City, NJFood/CosmeticsNo Action Indicated (NAI)2246354
Mar 28, 2016Commerce, CAFood/CosmeticsVoluntary Action Indicated (VAI)3004249953
Mar 31, 2015Atlanta, GAFood/CosmeticsNo Action Indicated (NAI)3008869000
Aug 7, 2014Atlanta, GAFood/CosmeticsOfficial Action Indicated (OAI)3008869000
May 3, 2013Jersey City, NJFood/CosmeticsVoluntary Action Indicated (VAI)2246354
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 Well Luck Co. Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 17, 2014.

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

6 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1000334921Houston, TX1Mar 13, 2026
FEI 2246354Jersey City, NJ6Sep 19, 2025
FEI 3008869000Atlanta, GA5Apr 17, 2025
FEI 3011967293Hayward, CA1Oct 18, 2024
FEI 3005344592Chicago, IL1Oct 26, 2021
FEI 3004249953Commerce, CA2Apr 22, 2021

Well Luck Co. Inc. and the FDA: common questions

Has Well Luck Co. Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Well Luck Co. Inc.. The most recent is dated Sep 17, 2014.

Has Well Luck Co. Inc. received an FDA Form 483?

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

When did the FDA last inspect Well Luck Co. Inc.?

The most recent FDA inspection on file ended Mar 13, 2026 at Houston, TX and was classified NAI. FDA has 16 inspections of Well Luck Co. 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.