Babylon, Inc. – FDA Warning Letter, May 8, 2020

On September 3, 2020, the FDA issued a Warning Letter to Babylon Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection conducted on May 7-8, 2020. The inspection, initiated due to Salmonella isolation from tahini imported by Babylon Inc. and manufactured by (b)(4), revealed significant violations of the FSVP regulation (21 CFR part 1 subpart L) and section 805 of the FD&C Act.

Babylon Inc. failed to develop, maintain, and follow an FSVP for imported tahini from (b)(4) and (b)(4), and for any other imported food products. Although the company voluntarily destroyed the Salmonella-contaminated tahini, this action does not address the FSVP violations. The FDA provided Form FDA 483a, FSVP Observations, but has not received a response.

The FDA requires Babylon Inc. to take prompt corrective action. Failure to comply may result in refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, and placement on detention without physical examination (DWPE) per Import Alert # 99-19. Importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

Babylon Inc. must respond in writing within fifteen working days, detailing corrective actions, including documentation like a