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Total Distribution, Inc. FDA Record

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

Total Distribution, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Total Distribution, Inc., the most recent on Nov 23, 2016.

What these totals cover: FDA records filed under the name "Total Distribution, Inc." and its spelling variant "Total Distribution".

Latest inspection: Apr 28, 2025 · NAI

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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	3	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

Total Distribution, Inc.'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	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	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.

Total Distribution, Inc. FDA Warning Letters

1 warning letter on Nov 23, 2016.

Issued	Subject	Issuing office	Close-out letter
Nov 23, 2016

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

3 inspections from Jul 15, 2019 to Apr 28, 2025.

Date	Site	Product	Classification	FEI
Apr 28, 2025	Bayonne, NJ	Food/Cosmetics	No Action Indicated (NAI)	3008932273
Aug 18, 2022	Winston Salem, NC	Food/Cosmetics	Voluntary Action Indicated (VAI)	1028814
Jul 15, 2019	Jacksonville, FL	Food/Cosmetics	No Action Indicated (NAI)	1000113518

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 Total Distribution, Inc.: warning letters, injunctions and seizures. It came from FDA's Center for Tobacco Products, which regulates tobacco retailers and manufacturers. It is not a drug, medical device or food manufacturing action.

Most recent: Warning Letter, Nov 23, 2016.

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

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3008932273	Bayonne, NJ	1	Apr 28, 2025
FEI 1028814	Winston Salem, NC	1	Aug 18, 2022
FEI 1000113518	Jacksonville, FL	1	Jul 15, 2019

Total Distribution, Inc. and the FDA: common questions

Has Total Distribution, Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Total Distribution, Inc.. The most recent is dated Nov 23, 2016.

Has Total Distribution, Inc. received an FDA Form 483?

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

When did the FDA last inspect Total Distribution, Inc.?

The most recent FDA inspection on file ended Apr 28, 2025 at Bayonne, NJ and was classified NAI. FDA has 3 inspections of Total Distribution, Inc. on file.

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