FDA WARNING_LETTER - Molino Enterprises One, Inc. - September 14, 2021

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Molino Enterprises One, Inc. from August 10 to September 14, 2021, following a previous inspection on April 5, 2019. The inspection aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found that Molino Enterprises One, Inc. is not in compliance with FSVP requirements for imported whole wheat breadsticks, (b)(4), and (b)(4) from a foreign supplier in (b)(4). Specifically, the company failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). A Form FDA 483a, FSVP Observations, was issued on September 14, 2021, but no response has been received.

Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.

Molino Enterprises One, Inc. must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g., a copy of