FDA WARNING_LETTER - Kim Nhung Marketplace Inc - May 21, 2021

On October 1, 2021, the FDA issued a Warning Letter to Kim Nhung Marketplace Inc. following Foreign Supplier Verification Programs (FSVP) inspections conducted from May 5-21, 2021, and previously on March 20, 2019. These inspections assessed compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers perform risk-based activities to verify imported food meets U.S. safety standards.

The inspections revealed significant violations: the firm failed to develop, maintain, and follow an FSVP for specific imported foods, including Frozen Taro, Frozen Steam Sweet Corn (with Husk), and Frozen Tapioca Noodle from (b)(4), and (b)(4) Rice (b)(4) from (b)(4). This non-compliance violates Section 805 of the FD&C Act and 21 CFR 1.502(a).

The firm received Form FDA 483a FSVP Observations after both inspections. While a response dated June 21, 2021, was acknowledged, the violations persist. Failure to promptly correct these issues may lead to further FDA action, including refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, and placement on detention without physical examination (DWPE) via Import Alert #