don’t run out – FDA Warning Letter, Dec 30, 2021

On March 11, 2022, the FDA issued a Warning Letter to Don’t Run Out dba Public Goods following a Foreign Supplier Verification Program (FSVP) inspection conducted from November 23, 2021, to December 30, 2021, at their New York, NY location. A previous inspection was also conducted on November 20, 2019. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1, subpart L).

The FDA found that Don’t Run Out dba Public Goods is not in compliance with FSVP requirements for "(b)(4) Ramen Noodles" imported from "(b)(4)". This constitutes a significant violation of section 805 of the FD&C Act. An FDA Form 483a, FSVP Observations, was issued on December 30, 2021, but no response has been received.

Failure to adequately address this violation may result in further action, including refusal of admission of imported food products under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) of the "(b)(4) Ramen Noodles" under Import Alert # 99-41. Additionally, importing food without