EH Maldonado and Company

Warning LetterOpen

Mr. Emilio H. Maldonado Owner EH Maldonado and Company 785 E. Frontage Rd. Rio Rico , AZ 85648 United StatesIssued Jul 28, 2022Division of Southwest Imports

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateJul 28, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: EH Maldonado and Company
Location: Mr. Emilio H. Maldonado Owner EH Maldonado and Company 785 E. Frontage Rd. Rio Rico , AZ 85648 United States
FEI Number: N/A
Country: United States
Issue Date: July 28, 2022
Issuing Office: Division of Southwest Imports
Product Type: Other
Status: Open

Summary

EH Maldonado and Company, a food importer based in Arizona, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) as required by federal law for imported foods including honeydew melons and mangoes. During an April 2022 inspection, the FDA found the company had not developed, maintained, or followed any FSVP procedures for the foods it imported, representing a significant violation of 21 CFR Part 1, Subpart L and Section 805 of the Federal Food, Drug, and Cosmetic Act. The company did not respond to the FDA's Form 483a observations issued at the conclusion of the inspection.

EH Maldonado and Company FDA Warning Letter, July 28, 2022