Del Valle Import Corp.

Warning LetterOpen

Jorge Avila Owner Del Valle Import Corp. 1231 Lafayette Ave Bronx , NY 10474 United StatesFEI 3013493563Issued Nov 1, 2022Division of Northeast 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 3013493563.

Violations2

Issue DateNov 1, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: Del Valle Import Corp.
Location: Jorge Avila Owner Del Valle Import Corp. 1231 Lafayette Ave Bronx , NY 10474 United States
FEI Number: 3013493563
Country: United States
Issue Date: November 01, 2022
Issuing Office: Division of Northeast Imports
Product Type: Other
Status: Open

Summary

Del Valle Import Corp. failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for imported fresh produce including dragon fruit, sweet melons, and fresh plantains, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. During inspections conducted in July-August 2022 (and previously in 2021), FDA investigators identified that the company had not implemented any FSVP for the foods it imported, despite the regulatory requirement for importers to perform risk-based verification activities to ensure imported foods meet U.S. food safety standards. The company did not respond to the FDA Form 483a observations issued on August 17, 2022, documenting these significant violations.

Del Valle Import Corp. FDA Warning Letter, November 1, 2022