FDA WARNING_LETTER - ITC Global Trading Inc. - May 19, 2021

On October 22, 2021, the FDA issued a Warning Letter to ITC Global Trading, Inc. following an FSVP inspection from April 30 to May 19, 2021, at their Houston, Texas location. Previous inspections occurred on August 4, 2017, and February 24, 2020. The inspection found the company non-compliant with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, regarding Foreign Supplier Verification Programs (FSVP) for imported foods.

Significant violations include: 1. Failure to develop, maintain, and follow an FSVP for imported foods such as Canned Mango and Passion Fruit Drink, Water Chestnuts in Syrup, and Coconut Meat in Syrup, as required by 21 CFR 1.502(a). 2. Failure to verify and document that thermally processed low-acid canned foods, specifically Water Chestnuts in Syrup and Coconut Meat in Syrup, were produced in accordance with 21 CFR Part 113, as required by 21 CFR 1.502(b)(1).

The company did not respond to the Form FDA 483a issued on May 19, 2021. Failure to adequately address these violations may lead to refusal of admission of imported food under Section 801(