Sree Nidhi Corp – FDA Warning Letter, Apr 21, 2022

On April 14-21, 2022, the FDA conducted an FSVP inspection of Sree Nidhi Corp, following an initial inspection on March 3, 2021. 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 food safety.

The FDA found Sree Nidhi Corp not in compliance with FSVP requirements, specifically failing to develop, maintain, and follow an FSVP for imported foods, including Karivepaku with Garlic Spices, Semolina Course Wheat, Maize Atta Corn Flour, and Frozen Mango Slices. This is a repeated violation, as a Form FDA 483a was issued on April 21, 2022, and no corrective action plan has been received.

Failure to correct these violations may lead to refusal of admission of 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). Sree Nidhi Corp must 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 should be sent to Ms. Ruth