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Santa Cruz Produce, Inc. FDA Record

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

Santa Cruz Produce, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Santa Cruz Produce, Inc., the most recent on Mar 8, 2023.

What these totals cover: FDA records filed under the name "Santa Cruz Produce, Inc." and its spelling variant "Santa Cruz Produce".

Latest inspection: Jun 13, 2024 · 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	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

Santa Cruz Produce, 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
2026	0	0	0
2025	0	0	0
2024	1	0	0
2023	0	0	1
2022	1	1	0
2021	1	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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Santa Cruz Produce, Inc. FDA Warning Letters

1 warning letter on Mar 8, 2023.

Issued	Subject	Issuing office	Close-out letter
Mar 8, 2023 · Letter on fda.gov	Foreign Supplier Verification Program (FSVP)	Division of Southeast Imports

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 Aug 24, 2021 to Jun 13, 2024.

Date	Site	Product	Classification	FEI
Jun 13, 2024	Nogales, AZ	Food/Cosmetics	No Action Indicated (NAI)	3015619394
Nov 14, 2022	Nogales, AZ	Food/Cosmetics	Official Action Indicated (OAI)	3015619394
Aug 24, 2021	Nogales, AZ	Food/Cosmetics	Voluntary Action Indicated (VAI)	3015619394

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 Santa Cruz Produce, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 8, 2023.

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 3015619394	Nogales, AZ	3	Jun 13, 2024

Santa Cruz Produce, Inc. and the FDA: common questions

Has Santa Cruz Produce, Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Santa Cruz Produce, Inc.. The most recent is dated Mar 8, 2023, with the subject "Foreign Supplier Verification Program (FSVP)".

Has Santa Cruz Produce, Inc. received an FDA Form 483?

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

When did the FDA last inspect Santa Cruz Produce, Inc.?

The most recent FDA inspection on file ended Jun 13, 2024 at Nogales, AZ and was classified NAI. FDA has 3 inspections of Santa Cruz Produce, Inc. on file, 1 of them classified OAI (official action indicated).

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