FDA WARNING_LETTER - Orchid Grocery - June 05, 2025

The FDA issued a warning letter to Orchid Grocery, located at 400 South Ave Ste 12, Middlesex, NJ, following an inspection conducted from May 22 to June 5, 2025. The inspection aimed to assess compliance with the Foreign Supplier Verification Program (FSVP) requirements under section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the corresponding regulations in 21 CFR part 1, subpart L. The FSVP mandates that importers verify that imported food meets U.S. safety standards.

The inspection revealed significant violations, notably the absence of a developed, maintained, and followed FSVP for any imported foods, contravening 21 CFR part 1.502(a). Orchid Grocery failed to provide a response to the Form FDA 483a, which detailed these observations.

The FDA has requested Orchid Grocery to respond within 15 working days, detailing corrective actions and providing supporting documentation, such as a copy of the FSVP and records of its implementation. Failure to address these issues may result in further actions, including refusal of food admission under section 801(a)(3) of the FD&C Act and potential detention without physical examination.

Orchid Grocery must ensure compliance with section 805 of the FD&C Act to avoid prohibited importation under section 301(zz). Responses should be directed to Stanley Nelson, Compliance Officer, at the FDA"s Division of Northeast Imports.