FDA 483 - R.R. Importaciones Inc. - October 05, 2023

During an FDA inspection conducted from October 3-5, 2023, at R.R. Importaciones Inc., located at 141 3rd St #143, Passaic, NJ 07055-7618, an observation was made regarding their Foreign Supplier Verification Program (FSVP). The inspection was led by Investigator Diane B Radice and the report was issued to Rogelio Martinez, President.

The sole observation noted was that R.R. Importaciones Inc. did not develop an FSVP. Specifically, the firm stated they lacked an FSVP for all foods imported between October 1, 2022, and September 30, 2023. These imported foods and their associated suppliers were detailed in an attachment, marked with an "X" in the "No FSVP" column. This finding indicates a deficiency in the firm's compliance with regulations enforced by the Food and Drug Administration, particularly concerning Section 805 of the Federal Food, Drug and Cosmetic Act related to foreign supplier verification.