Karla Gissel Soto Munoz
Owner
Fuentes Farms LLC
2501 W Military Hwy Ste C21-C22
McAllen , TX 78503-8955
United StatesFEI 3013419413Issued Oct 14, 2022Division of Southwest Imports
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 3013419413.
Violations2
Issue DateOct 14, 2022
Product TypeOther
StatusOpen
Letter Details
Firm
Fuentes Farms LLC
Location
Karla Gissel Soto Munoz
Owner
Fuentes Farms LLC
2501 W Military Hwy Ste C21-C22
McAllen , TX 78503-8955
United States
FEI Number
3013419413
Country
United States
Issue Date
October 14, 2022
Issuing Office
Division of Southwest Imports
Product Type
Other
Status
Open
Summary
Fuentes Farms LLC, a food importer based in McAllen, Texas, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) for imported fresh produce including green onions, chayote, and broccoli, in violation of FDA regulations. The company did not develop any FSVP documentation for the covered produce it imported from foreign suppliers, nor did it respond to the FDA's Form 483a observations issued on August 1, 2022, following an inspection conducted July 28–August 1, 2022. This represented a significant compliance failure with Section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1, Subpart L, which requires importers to perform risk-based verification activities ensuring imported food meets U.S. safety standards.
Fuentes Farms LLC FDA Warning Letter, October 14, 2022