Bulls Bay Enterprises, Inc. FDA Record

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

Bulls Bay Enterprises, Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bulls Bay Enterprises, Inc." is on file.

What these totals cover: FDA records filed under the name "Bulls Bay Enterprises, Inc." and its spelling variant "Bulls Bay Enterprises".

Latest inspection
Apr 28, 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
Inspections4Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

4 inspections from Dec 10, 2008 to Apr 28, 2025.

DateSiteProductClassificationFEI
Apr 28, 2025Mc Clellanville, SCFood/CosmeticsNo Action Indicated (NAI)1044262
Oct 30, 2014Mc Clellanville, SCFood/CosmeticsNo Action Indicated (NAI)1044262
Sep 6, 2012Mc Clellanville, SCFood/CosmeticsNo Action Indicated (NAI)1044262
Dec 10, 2008Mc Clellanville, SCFood/CosmeticsNo Action Indicated (NAI)1044262
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 1044262Mc Clellanville, SC4Apr 28, 2025

Bulls Bay Enterprises, Inc. and the FDA: common questions

Has Bulls Bay Enterprises, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Bulls Bay Enterprises, 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 Bulls Bay Enterprises, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Bulls Bay Enterprises, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Bulls Bay Enterprises, Inc.?

The most recent FDA inspection on file ended Apr 28, 2025 at Mc Clellanville, SC and was classified NAI. FDA has 4 inspections of Bulls Bay Enterprises, Inc. on file.

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