Supreme Manufacturing Co, Inc. FDA Record

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

Supreme Manufacturing Co, Inc. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Supreme Manufacturing Co, Inc." is on file.

What these totals cover: FDA records filed under the name "Supreme Manufacturing Co, Inc." and its spelling variant "Supreme Manufacturing Co".

Latest inspection
Apr 1, 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
Inspections7Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Supreme Manufacturing Co, Inc.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202210000
202100000
202000000
201910000
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

7 inspections from Sep 17, 2009 to Apr 1, 2025.

DateSiteProductClassificationFEI
Apr 1, 2025East Brunswick, NJFood/CosmeticsNo Action Indicated (NAI)3000325163
Sep 30, 2022East Brunswick, NJFood/CosmeticsNo Action Indicated (NAI)3000325163
Sep 23, 2019East Brunswick, NJFood/CosmeticsVoluntary Action Indicated (VAI)3000325163
Sep 30, 2016East Brunswick, NJFood/CosmeticsVoluntary Action Indicated (VAI)3000325163
Aug 8, 2013East Brunswick, NJFood/CosmeticsVoluntary Action Indicated (VAI)3000325163
Jun 17, 2010East Brunswick, NJFood/CosmeticsVoluntary Action Indicated (VAI)3000325163
Sep 17, 2009East Brunswick, NJFood/CosmeticsNo Action Indicated (NAI)3000325163
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 3000325163East Brunswick, NJ7Apr 1, 2025

Supreme Manufacturing Co, Inc. and the FDA: common questions

Has Supreme Manufacturing Co, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Supreme Manufacturing Co, Inc." 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 Supreme Manufacturing Co, Inc. received an FDA Form 483?

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

When did the FDA last inspect Supreme Manufacturing Co, Inc.?

The most recent FDA inspection on file ended Apr 1, 2025 at East Brunswick, NJ and was classified NAI. FDA has 7 inspections of Supreme Manufacturing Co, Inc. on file.

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