FDA EIR - Noatum Logistics USA, Llc - May 15, 2025

An FDA inspection was conducted at Noatum Logistics USA, LLC, a food product distributor located in Doral, FL, from May 14-15, 2025. This unannounced, comprehensive surveillance inspection, conducted under the regulatory framework of 21 CFR 117 for Preventive Controls and Sanitary Human Food Operations, covered the firm's receiving, storage, and distribution of mixed food items, including imported coffee.

The main issue identified during the inspection, documented in an FDA 483 observation, was the company's failure to adequately exclude pests from its food plant. Specifically, investigators observed multiple rear bay doors open upon arrival, which could allow pests to enter and potentially contaminate food products.

During the closeout meeting, Mrs. Heysell Ortiz, the Branch Manager, acknowledged the violation. She provided assurance that corrective actions would be promptly implemented, committing to ensuring that the rear bay doors would remain closed at all times when not actively in use for deliveries or pickups, thereby preventing pest access. No refusals were encountered, and no samples were collected. The company had no prior domestic FDA inspection history, and no consumer complaints or recalls were found in the system.