FDA WARNING_LETTER - David Rosen Bakery Supplies Company, Inc. - February 05, 2020

On February 5, 2020, the FDA conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at David Rosen Bakery Supplies Inc., following an initial inspection on July 26, 2018. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act and 21 CFR part 1 subpart L. The firm was found not in compliance with FSVP requirements for Strawberry Filling Diamante, Pineapple Filling Diamante, and Multicolor Sprinkles Diamante, all manufactured by Grupo La Florida Mexico S.A. de C.V. Specifically, David Rosen Bakery Supplies Inc. failed to develop, maintain, and follow an FSVP for these imported foods, as required by 21 CFR 1.502(a). This constitutes a significant violation, as importers must perform risk-based activities to verify imported food meets U.S. food safety standards. The firm had not responded to previous Form FDA 483a observations. David Rosen Bakery Supplies Inc. must respond in writing within fifteen working days, detailing corrective actions, including documentation like a copy of their FSVP and implementation records. Failure to promptly correct these violations may result in refusal of admission for the affected products under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE), and is prohibited under section 301(zz) of the FD&C Act.