International General Trading Corp.

Warning LetterOpen

Gary Taneja President International General Trading Corp. 566 7th Ave, 8th Floor Room 804 New York , NY 10018-1802 United StatesFEI 3011490882Issued Jun 17, 2021Division of Northeast Imports

View Letter

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 3011490882.

Violations1

Issue DateJun 17, 2021

Product TypeOther

StatusOpen

Letter Details

Firm: International General Trading Corp.
Location: Gary Taneja President International General Trading Corp. 566 7th Ave, 8th Floor Room 804 New York , NY 10018-1802 United States
FEI Number: 3011490882
Country: United States
Issue Date: June 17, 2021
Issuing Office: Division of Northeast Imports
Product Type: Other
Status: Open

Summary

International General Trading Corp. failed to establish Foreign Supplier Verification Programs (FSVPs) for noodles, wafers, and hazelnut spread imported from foreign suppliers, violating section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1 subpart L. During a March-April 2021 remote inspection, FDA investigators identified these significant compliance gaps and provided Form FDA 483a observations, to which the company had not responded as of the warning letter date. This represented a repeat violation, as a prior FSVP inspection in August 2018 had also documented deficiencies without adequate corrective action.

International General Trading Corp. FDA Warning Letter, June 17, 2021