FDA 483 - Skjodt-Barrett Contract Packaging LLC - September 19, 2025

This FDA Form 483 was issued to Skjodt-Barrett Contract Packaging LLC following an inspection conducted from September 3-19, 2025. The document details significant observations concerning food safety, particularly for products intended for infants and young children. The primary violations include an inadequate hazard analysis for heavy metals and insufficient pest control measures, indicating non-compliance with the Federal Food, Drug, and Cosmetic Act and associated food safety regulations.The firm's hazard analysis for ready-to-serve fruit purees, smoothies, and infant food pouches identified heavy metal contamination (lead, cadmium, arsenic, mercury) but deemed it a "low risk" not requiring a Critical Control Point. Inspectors found that the company did not test ingredients for heavy metals, supplier agreements lacked specific controls for these contaminants, and finished product testing procedures were undocumented. Evidence showed finished infant food products with detected lead levels, with one lot testing at 10 ppb internally but 21 ppb by a state lab, and another lot shipped without any heavy metal testing.Furthermore, the inspection revealed unsanitary conditions due to pest activity. Numerous rat excreta pellets and a chewed product pouch were discovered in the warehouse. Pest control records indicated ongoing rodent issues dating back to March 2025.The company is required to take prompt corrective actions, including revising its hazard analysis to effectively control heavy metal contamination, implementing robust ingredient and finished product testing, ensuring comprehensive supplier controls, and establishing effective pest exclusion programs to prevent product contamination.