FDA EIR - Mead Johnson Nutrition - September 17, 2014

Mead Johnson Nutrition's Evansville facility underwent a routine surveillance inspection by the FDA from September 9-17, 2014. The inspection covered the company's infant formula manufacturing operations for liquid concentrate, ready-to-use, and powder formulas, conducted under the regulatory frameworks of the Infant Formula Program and Domestic Acidified and Low-Acid Canned Foods Program. While no formal FDA 483 Inspectional Observations form was issued at the conclusion of the inspection, a key issue noted was the company's refusal to provide FDA investigators with environmental monitoring results and records, citing internal company policy. Additionally, minor observations regarding small rust-like spots on a bottle filler ceiling and a sticky floor in a walk-in cooler were discussed with management. The document also detailed Mead Johnson's internal investigations and corrective actions for previously rejected infant formula batches that were out of nutrient specification, leading to updates in master batch records and testing protocols.