Mr. Carlos Alberto Toto Cortes
President/Owner
Premium Fresh Growers LLC
4900 W. Expressway 83, Suite 202
McAllen , TX 78501
United States
dc@premiumfreshgrowers.comFEI 3016484598Issued Dec 18, 2024Division 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 3016484598.
Violations2
Issue DateDec 18, 2024
Product TypeOther
StatusOpen
Letter Details
Firm
Premium Fresh Growers LLC
Location
Mr. Carlos Alberto Toto Cortes
President/Owner
Premium Fresh Growers LLC
4900 W. Expressway 83, Suite 202
McAllen , TX 78501
United States
dc@premiumfreshgrowers.com
FEI Number
3016484598
Country
United States
Issue Date
December 18, 2024
Issuing Office
Division of Southwest Imports
Product Type
Other
Status
Open
Summary
Premium Fresh Growers LLC failed to develop and maintain a Foreign Supplier Verification Program (FSVP) for imported fresh produce including limes, cilantro, and carrots, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. An FDA inspection conducted from October 24 to November 25, 2024, identified that the company had not implemented required risk-based verification activities to ensure imported foods met applicable U.S. food safety standards. The company did not respond to the Form FDA 483a observations issued on November 25, 2024, documenting the compliance failures.
Premium Fresh Growers LLC FDA Warning Letter, December 18, 2024
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