Ruth Special Food Store LLC

Warning LetterOpen

Mr. Paul Chen Owner Ruth Special Food Store LLC 95 Washington Ave Belleville , NJ 07109 United StatesFEI 3011153529Issued Dec 9, 2022Division of Northeast Imports

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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 3011153529.

Violations1

Issue DateDec 9, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: Ruth Special Food Store LLC
Location: Mr. Paul Chen Owner Ruth Special Food Store LLC 95 Washington Ave Belleville , NJ 07109 United States
FEI Number: 3011153529
Country: United States
Issue Date: December 09, 2022
Issuing Office: Division of Northeast Imports
Product Type: Other
Status: Open

Summary

Ruth Special Food Store LLC failed to comply with Foreign Supplier Verification Program (FSVP) requirements for imported food products, including organic and conventional pumpkin kernels and dry roasted edamame. The company did not develop, maintain, or follow an FSVP plan as required by section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1, Subpart L, despite FDA inspections conducted in 2021 and again in August-September 2022. The FDA provided a Form FDA 483a with observations on September 19, 2022, but the company did not submit a response to these findings.

Ruth Special Food Store LLC FDA Warning Letter, December 9, 2022