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 3014268867.
Violations2
Issue DateJun 21, 2023
Product TypeOther
StatusOpen
Letter Details
Firm
Fruits Tress, Inc.
Location
Owner
Fruits Tress, Inc.
Nahum Tress Marini
1401 W. Anaya Rd. Apt. 2305
Pharr , TX 78577
United States
FEI Number
3014268867
Country
United States
Issue Date
June 21, 2023
Issuing Office
Division of Southwest Imports
Product Type
Other
Status
Open
Summary
Fruits Tress, Inc., an importer of fresh produce including watermelon and papaya, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by the Federal Food, Drug, and Cosmetic Act and implementing regulations. During inspections conducted in April 2023 (and previously in November 2021), the FDA found the company had not established an FSVP for any of the foods it imported, representing a significant violation of 21 CFR Part 1 Subpart L. The company did not respond to the FDA 483a observations issued on April 14, 2023, compounding the compliance failures.
Fruits Tress, Inc. FDA Warning Letter, June 21, 2023