STB Quarters, LLC

Warning LetterOpen

Tolga Gerdek President STB Quarters, LLC 4000 W. Montrose Ave. Chicago , IL 60641 United StatesFEI 3021152571Issued Jun 8, 2021Division of Northern Border Imports

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Violations2

Issue DateJun 8, 2021

Product TypeOther

StatusOpen

Letter Details

Firm: STB Quarters, LLC
Location: Tolga Gerdek President STB Quarters, LLC 4000 W. Montrose Ave. Chicago , IL 60641 United States
FEI Number: 3021152571
Country: United States
Issue Date: June 08, 2021
Issuing Office: Division of Northern Border Imports
Product Type: Other
Status: Open

Summary

STB Quarters, LLC, an importer of food products including tahini/sesame paste and sesame seeds, failed to establish Foreign Supplier Verification Programs (FSVP) as required under the Federal Food, Drug and Cosmetic Act. During a remote inspection conducted from February to March 2021, the FDA found that the company did not develop, maintain, or follow FSVPs for any of the foods it imported from foreign suppliers, resulting in significant non-compliance with 21 CFR Part 1 Subpart L. The company did not respond to the FDA's Form FDA 483a observations issued at the conclusion of the inspection.

STB Quarters, LLC FDA Warning Letter, June 8, 2021