Warren Produce Co., LLC FDA Record

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

Warren Produce Co., LLC has 1 FDA recall (1 Class I), 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Warren Produce Co., LLC" is on file.

What these totals cover: FDA records filed under the name "Warren Produce Co., LLC" and its spelling variant "Warren Produce Co".

Latest recall
F-2036-2016 · Class I · Jul 22, 2016
Latest inspection
Apr 2, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1 (1 Class I)Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent recalls

1 recall record on Jul 22, 2016.

NumberClassProductDate
F-2036-2016Class IPrimo Fresh Serrano Peppers Distributed by Warren Produce, 824 W. Monte Cristo Rd, Edinburg, TX…Jul 22, 2016

Recent FDA inspections

2 inspections from Jun 8, 2016 to Apr 2, 2025.

DateSiteProductClassificationFEI
Apr 2, 2025Edinburg, TXFood/CosmeticsVoluntary Action Indicated (VAI)3004347620
Jun 8, 2016Edinburg, TXFood/CosmeticsVoluntary Action Indicated (VAI)3004347620
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004347620Edinburg, TX2Apr 2, 2025

Warren Produce Co., LLC and the FDA: common questions

Has Warren Produce Co., LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Warren Produce Co., LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Warren Produce Co., LLC received an FDA Form 483?

FDA has not published a Form 483 for "Warren Produce Co., LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Warren Produce Co., LLC?

The most recent FDA inspection on file ended Apr 2, 2025 at Edinburg, TX and was classified VAI. FDA has 2 inspections of Warren Produce Co., LLC on file.

Has Warren Produce Co., LLC had an FDA recall?

Yes. Warren Produce Co., LLC has 1 FDA recall on record, 1 of them Class I, the most serious class. The most recent started Jul 22, 2016.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.