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Intershell International Corp. FDA Record

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

Intershell International Corp. has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Intershell International Corp., the most recent on Sep 26, 2014.

What these totals cover: FDA records filed under the name "Intershell International Corp." and its spelling variants "Intershell International", "Intershell International Corporation".

Latest inspection: Mar 27, 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	10	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Intershell International Corp.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	2	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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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Intershell International Corp. FDA Warning Letters

1 warning letter on Sep 26, 2014.

Issued	Subject	Issuing office	Close-out letter
Sep 26, 2014 · 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

10 inspections from Jul 9, 2009 to Mar 27, 2025.

Date	Site	Product	Classification	FEI
Mar 27, 2025	Gloucester, MA	Food/Cosmetics	No Action Indicated (NAI)	3010583758
Mar 26, 2025	Gloucester, MA	Food/Cosmetics	Voluntary Action Indicated (VAI)	3010583758
Dec 7, 2023	Gloucester, MA	Food/Cosmetics	Voluntary Action Indicated (VAI)	3010583758
Dec 1, 2017	Gloucester, MA	Food/Cosmetics	Voluntary Action Indicated (VAI)	3010583758
Dec 31, 2014	Gloucester, MA	Food/Cosmetics	No Action Indicated (NAI)	3010583758
Aug 29, 2014	Gloucester, MA	Food/Cosmetics	Official Action Indicated (OAI)	3010583758
Nov 26, 2013	Gloucester, MA	Food/Cosmetics	No Action Indicated (NAI)	3010583758
Apr 7, 2010	Gloucester, MA	Food/Cosmetics	Voluntary Action Indicated (VAI)	3010583758
Sep 4, 2009	Gloucester, MA	Food/Cosmetics	No Action Indicated (NAI)	3003074118
Jul 9, 2009	Gloucester, MA	Food/Cosmetics	No Action Indicated (NAI)	3003074118

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 Intershell International Corp.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 26, 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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3010583758	Gloucester, MA	8	Mar 27, 2025
FEI 3003074118	Gloucester, MA	2	Sep 4, 2009

Intershell International Corp. and the FDA: common questions

Has Intershell International Corp. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Intershell International Corp.. The most recent is dated Sep 26, 2014.

Has Intershell International Corp. received an FDA Form 483?

FDA has not published a Form 483 for "Intershell International Corp." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Intershell International Corp.?

The most recent FDA inspection on file ended Mar 27, 2025 at Gloucester, MA and was classified NAI. FDA has 10 inspections of Intershell International Corp. on file, 1 of them classified OAI (official action indicated).

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