El Molino Bakery Supplies Inc – FDA Warning Letter, Sep 12, 2019

On September 12, 2019, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at 2875 N Berkeley Lake Rd NW Ste 19, Duluth, GA, following an initial inspection on July 10, 2018. The purpose was to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers perform risk-based activities to verify imported food meets U.S. safety standards.

The inspection revealed the firm did not have FSVPs for imported products, including Multi-color sprinkles, Strawberry filling, and Bavarian cream from foreign supplier (b)(4). This deficiency was noted during both the 2018 and 2019 inspections. The firm failed to respond to the Form FDA 483a, FSVP Observations, issued after both inspections.

These violations constitute non-compliance with Section 805 of the FD&C Act. Failure to promptly correct these issues may lead to further action, including refusal of admission for the specified products under Section 801(a)(3) of the FD&C Act, potentially resulting in 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.

The firm