FDA 483 - Sojitz Corporation of America - August 11, 2023

During an FDA inspection of Sojitz Corporation of America, located at 1120 Avenue of the Americas, New York, NY, from August 2 to August 11, 2023, observations were made regarding their Foreign Supplier Verification Program (FSVP). The inspection was issued to Alexander Pellerito, VP & Senior Counsel of Trade Compliance.

Observation 1 noted that Sojitz Corporation of America did not develop an FSVP. Specifically, the firm did not follow a written set of FSVP procedures outlined in their "US FSMA Preventive Control Plan for Importers." This included failing to determine known or reasonably foreseeable hazards for each food, evaluate risk based on hazard analysis and foreign supplier performance, use this evaluation to approve suppliers and determine verification activities, conduct supplier verification activities, and perform corrective actions. This deficiency was observed for Monodicalcium Phosphate imported from (b) (4), Caustic Calcined Magnesite imported from (b) (4), and Palmitic Acid imported from (b) (4).

Observation 2 stated that the firm did not provide an English translation of an FSVP record maintained in a language other than English. Specifically, a HACCP Plan for supplier (b) (4) was provided in a foreign language. These observations were reported by Investigator Christian Parra on August 11, 2023.