Nutricia North America Inc. – FDA EIR, May 14, 2019

An FDA inspection of Nutricia North America, a manufacturer of medical foods located in Cedar Knolls, NJ, was conducted on May 14, 2019. The inspection, carried out under the Medical Foods Program guidance (CP 7321.002), focused on the firm's operations related to products for individuals with Phenylketonuria (PKU), Maple Syrup Urine Disease (MSUD), and Glutaric Aciduria Type 1 (GA-1).

During the comprehensive one-day inspection, no deviations were observed across critical areas including receiving/shipping docks, raw materials and finished product storage, can preparation, blending and canning, pouching, and packaging/labeling. The inspection also confirmed the absence of any insect, rodent, or avian activity within the facility.

Notably, no FDA Form 483, Inspectional Observations, was issued, indicating a high level of compliance. The report highlighted the company's robust quality systems, including the segregation of allergen-containing ingredients, rigorous testing of products for microbiological contamination and offending amino acids, and comprehensive cleaning verification procedures. Employees receive thorough training on GMP, FSMA, and other quality programs. The firm has also maintained its positive status from the previous inspection in September 2018, which was classified as "No Action Indicated." No immediate regulatory actions were required as a result of this inspection.