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Sundial Herbs And Herbal Products Enterprise FDA Record

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

Latest inspection NAI · Jun 25, 2025
Last warning letter 2013

Inspections 5

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest May 24, 2013

510(k) clearances 0 None on file

Sundial Herbs And Herbal Products Enterprise has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 1 warning letter to Sundial Herbs And Herbal Products Enterprise, the most recent on May 24, 2013.

What these totals cover: FDA records filed under the name "Sundial Herbs And Herbal Products Enterprise".

Latest inspection: Jun 25, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Sundial Herbs And Herbal Products Enterprise's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Sundial Herbs And Herbal Products Enterprise: FDA inspections per year

Year	Inspections	OAI
2026	0	0
2025	1	0
2024	0	0
2023	0	0
2022	0	0
2021	1	0
2020	0	0
2019	0	0
2018	0	0
2017	1	1

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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Sundial Herbs And Herbal Products Enterprise FDA Warning Letters

1 warning letter on May 24, 2013.

Issued	Subject	Issuing office	Close-out letter
May 24, 2013 · Record page

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

5 inspections from Nov 15, 2012 to Jun 25, 2025.

Date	Site	Product	Classification	FEI
Jun 25, 2025	Bronx, NY	Food/Cosmetics	No Action Indicated (NAI)	1000119548
Apr 19, 2021	Bronx, NY	Drugs	No Action Indicated (NAI)	1000119548
Feb 17, 2017	Bronx, NY	Food/Cosmetics	Official Action Indicated (OAI)	1000119548
Feb 12, 2014	Bronx, NY	Food/Cosmetics	Voluntary Action Indicated (VAI)	1000119548
Nov 15, 2012	Bronx, NY	Food/Cosmetics	Official Action Indicated (OAI)	1000119548

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 2 compliance actions under Sundial Herbs And Herbal Products Enterprise: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Injunction, May 27, 2020.

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000119548	Bronx, NY	5	Jun 25, 2025

Sundial Herbs And Herbal Products Enterprise and the FDA: common questions

Has Sundial Herbs And Herbal Products Enterprise received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Sundial Herbs And Herbal Products Enterprise. The most recent is dated May 24, 2013.

Has Sundial Herbs And Herbal Products Enterprise received an FDA Form 483?

FDA has not published a Form 483 for "Sundial Herbs And Herbal Products Enterprise" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sundial Herbs And Herbal Products Enterprise?

The most recent FDA inspection on file ended Jun 25, 2025 at Bronx, NY and was classified NAI. FDA has 5 inspections of Sundial Herbs And Herbal Products Enterprise on file, 2 of them classified OAI (official action indicated).

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