K D Singh Enterprises LLC – FDA Warning Letter, Feb 19, 2020

On April 8, 2020, the FDA issued a Warning Letter to K D Singh Enterprises LLC following a Foreign Supplier Verification Program (FSVP) inspection on February 19, 2020, and an initial inspection on August 23, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to ensure imported food meets U.S. safety standards.

The firm was found non-compliant for not developing, maintaining, and following FSVPs for wheat flour, spice mix, and paneer imported from specific foreign suppliers. This violates section 805 of the FD&C Act and 21 CFR part 1 subpart L. The FDA investigator issued Form FDA 483a, FSVP Observations, after both inspections, but no response has been received.

Failure to promptly correct these significant violations may lead to further FDA action, including refusal of admission for the implicated products under section 801(a)(3) of the FD&C Act, potentially resulting in detention without physical examination (DWPE) under Import Alert # 99-41. Additionally, importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

K D Singh Enterprises LLC must respond in writing within