Blue Stone Import USA Inc.

Warning LetterOpen

Mr. Scott Shin Owner Blue Stone Import USA Inc. 1129 Northern Blvd Ste 404 Manhasset , NY 11030 United StatesFEI 3013546928Issued Aug 3, 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 3013546928.

Violations1

Issue DateAug 3, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: Blue Stone Import USA Inc.
Location: Mr. Scott Shin Owner Blue Stone Import USA Inc. 1129 Northern Blvd Ste 404 Manhasset , NY 11030 United States
FEI Number: 3013546928
Country: United States
Issue Date: August 03, 2022
Issuing Office: Division of Northeast Imports
Product Type: Other
Status: Open

Summary

Blue Stone Import USA Inc., a food importer based in New York, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation for imported food products including spicy chicken flavor ramen and wheat flour. The company did not develop, maintain, or follow any FSVP plan as required by the Federal Food, Drug, and Cosmetic Act, despite being subject to FDA inspections in May 2019, February 2021, and most recently May-June 2022. The company also failed to respond to the FDA Form 483a observations issued at the conclusion of the June 2022 inspection, which documented these significant violations.

Blue Stone Import USA Inc. FDA Warning Letter, August 3, 2022