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Pinnacle Labs Of Tennessee, LLC FDA Record

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

Latest inspection OAI · Nov 3, 2023
Last warning letter 2024

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Apr 17, 2024

510(k) clearances 0 None on file

Pinnacle Labs Of Tennessee, LLC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Pinnacle Labs Of Tennessee, LLC, the most recent on Apr 17, 2024.

What these totals cover: FDA records filed under the name "Pinnacle Labs Of Tennessee, LLC" and its spelling variant "Pinnacle Labs Of Tennessee".

Latest inspection: Nov 3, 2023 · OAI

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	1	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Pinnacle Labs Of Tennessee, LLC: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	1
2023	1	1	0
2022	0	0	0
2021	0	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	0
2017	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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Pinnacle Labs Of Tennessee, LLC FDA Warning Letters

1 warning letter on Apr 17, 2024.

Issued	Subject	Issuing office	Close-out letter
Apr 17, 2024 · 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

1 inspection on Nov 3, 2023.

Date	Site	Product	Classification	FEI
Nov 3, 2023	Nashville, TN	Devices	Official Action Indicated (OAI)	3010982075

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 Pinnacle Labs Of Tennessee, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 17, 2024.

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 3010982075	Nashville, TN	1	Nov 3, 2023

Pinnacle Labs Of Tennessee, LLC and the FDA: common questions

Has Pinnacle Labs Of Tennessee, LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Pinnacle Labs Of Tennessee, LLC. The most recent is dated Apr 17, 2024.

Has Pinnacle Labs Of Tennessee, LLC received an FDA Form 483?

FDA has not published a Form 483 for "Pinnacle Labs Of Tennessee, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Pinnacle Labs Of Tennessee, LLC?

The most recent FDA inspection on file ended Nov 3, 2023 at Nashville, TN and was classified OAI. FDA has 1 inspection of Pinnacle Labs Of Tennessee, LLC on file, 1 of them classified OAI (official action indicated).

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