ISPE Produce, Inc.

Warning LetterOpen

Mr. Isidoro Perez President ISPE Produce, Inc. 2501 W. Military Hwy, B-4 McAllen , TX 78503-8955 United StatesFEI 3012324786Issued Apr 23, 2024Division of Southwest Imports

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012324786.

Violations1

Issue DateApr 23, 2024

Product TypeOther

StatusOpen

Letter Details

Firm: ISPE Produce, Inc.
Location: Mr. Isidoro Perez President ISPE Produce, Inc. 2501 W. Military Hwy, B-4 McAllen , TX 78503-8955 United States
FEI Number: 3012324786
Country: United States
Issue Date: April 23, 2024
Issuing Office: Division of Southwest Imports
Product Type: Other
Status: Open

Summary

ISPE Produce, Inc., an importer of fresh produce including Roma tomatoes, bell peppers, and lettuce, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by FDA regulations. During inspections conducted in July 2023 and February 2024, the FDA found that the company had not established any FSVP for the foods it imported, representing a significant violation of section 805 of the Federal Food, Drug and Cosmetic Act and 21 CFR part 1, subpart L. The company did not respond to the FDA's Form 483a observations issued on February 29, 2024, compounding the compliance failure.

ISPE Produce, Inc. FDA Warning Letter, April 23, 2024