FDA WARNING_LETTER - Rong Shing Trading NY Inc. - March 24, 2021

On June 15, 2021, the FDA issued a Warning Letter to Double R Trading Inc (Aka - Rong Shing Trading NY, Inc.) following remote Foreign Supplier Verification Program (FSVP) inspections conducted from March 9-24, 2021, and previously on November 22, 2019. The inspections assessed compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found the company non-compliant with FSVP requirements for dried black fungus from one foreign supplier and mix candy and Glam Day lollipops from another.

Specific violations include: 1. Failure to develop, maintain, and follow an FSVP for mix candy and Glam Day lollipops, as required by 21 CFR 1.502(a). 2. Failure to conduct and document supplier verification activities for dried black fungus from the foreign supplier, as required by 21 CFR 1.506(e)(1).

The company received Form FDA 483a, FSVP Observations, after both inspections but had not responded to the most recent one. Failure to address these violations may lead to refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-4