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Grindstone Neck Of Maine, LLC FDA Record

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

Latest inspection VAI · Aug 21, 2024
Last warning letter 2012

Inspections 7

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 18, 2012

510(k) clearances 0 None on file

Grindstone Neck Of Maine, LLC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Grindstone Neck Of Maine, LLC, the most recent on Sep 18, 2012.

What these totals cover: FDA records filed under the name "Grindstone Neck Of Maine, LLC" and its spelling variant "Grindstone Neck Of Maine".

Latest inspection: Aug 21, 2024 · VAI

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	7	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

Grindstone Neck Of Maine, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Grindstone Neck Of Maine, LLC: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	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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Grindstone Neck Of Maine, LLC FDA Warning Letters

1 warning letter on Sep 18, 2012.

Issued	Subject	Issuing office	Close-out letter
Sep 18, 2012 · 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

7 inspections from Nov 17, 2010 to Aug 21, 2024.

Date	Site	Product	Classification	FEI
Aug 21, 2024	Winter Harbor, ME	Food/Cosmetics	Voluntary Action Indicated (VAI)	3003693221
Oct 7, 2020	Winter Harbor, ME	Food/Cosmetics	Voluntary Action Indicated (VAI)	3003693221
Sep 1, 2017	Winter Harbor, ME	Food/Cosmetics	Voluntary Action Indicated (VAI)	3003693221
Aug 7, 2014	Winter Harbor, ME	Food/Cosmetics	No Action Indicated (NAI)	3003693221
Jun 6, 2013	Winter Harbor, ME	Food/Cosmetics	Voluntary Action Indicated (VAI)	3003693221
Aug 10, 2012	Winter Harbor, ME	Food/Cosmetics	Official Action Indicated (OAI)	3003693221
Nov 17, 2010	Winter Harbor, ME	Food/Cosmetics	Voluntary Action Indicated (VAI)	3003693221

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 Grindstone Neck Of Maine, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 18, 2012.

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 3003693221	Winter Harbor, ME	7	Aug 21, 2024

Grindstone Neck Of Maine, LLC and the FDA: common questions

Has Grindstone Neck Of Maine, LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Grindstone Neck Of Maine, LLC. The most recent is dated Sep 18, 2012.

Has Grindstone Neck Of Maine, LLC received an FDA Form 483?

FDA has not published a Form 483 for "Grindstone Neck Of Maine, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Grindstone Neck Of Maine, LLC?

The most recent FDA inspection on file ended Aug 21, 2024 at Winter Harbor, ME and was classified VAI. FDA has 7 inspections of Grindstone Neck Of Maine, LLC on file, 1 of them classified OAI (official action indicated).

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