woobo llc – FDA Warning Letter, Sep 16, 2020
On January 20, 2021, the FDA issued a Warning Letter to Woobo LLC dba Purunchon, Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from September 11-16, 2020. This inspection, along with previous ones on December 13, 2018, and August 9, 2019, aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.
The primary violation identified was the failure to develop, maintain, and follow an FSVP for imported Napa cabbage kimchi from (b)(4), soybean paste from (b)(4), and (b)(4) from (b)(4), as required by 21 CFR 1.502(a). This constitutes a significant violation of section 805 of the FD&C Act.
The FDA noted that FSVP Observations (Form FDA 483a) were provided after each inspection, and a meeting was held on May 26, 2020, to discuss findings. While a September 29, 2020, email response was acknowledged, the violations remained.
Further comments included the lack of written procedures for approving foreign suppliers based on performance and risk, as required by 21 CFR 1.506(a)(
ID · 7b08ad9c-314b-4e7d-94aa-363cc77141f3
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.