FDA WARNING_LETTER - Capital Imports LLC - December 15, 2022

On February 22, 2023, the FDA issued a Warning Letter to Capital Imports LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from November 4 to December 15, 2022. The inspection, aimed at assessing compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, found significant violations.

Specifically, Capital Imports LLC failed to develop, maintain, and follow an FSVP for any imported foods, a direct violation of 21 CFR 1.502(a). The company did not respond to the Form FDA 483a FSVP Observations issued on December 15, 2022.

The FDA stated that failure to adequately address these violations could lead to further 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 #99-41. Additionally, importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

Capital Imports LLC was required to respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g., a copy of their FSVP and implementation records), or explaining any delays. The response was to be sent to Julie Scoma, Compliance Officer, Division