FDA EIR - Mead Johnson & Company, LLC - September 15, 2016

An FDA inspection of Mead Johnson Nutrition's Evansville, Indiana facility occurred from September 12-15, 2016. The inspection focused on infant formula processing, including hydrostat retort operations for 8 oz. plastic bottles and powder blending. Significantly, the FDA did not issue a Form 483, Inspectional Observations, at the conclusion of the inspection, indicating no major deficiencies requiring immediate regulatory action. However, one procedural item was brought to management's attention: a Low Acid Canned Food (LACF) sterilization record for a specific infant formula batch was reviewed and signed more than one working day after its production. Mead Johnson management acknowledged this observation and committed to ensuring adherence to required record review timeframes internally. The inspection provided guidance on FSMA rules, including Preventive Controls for Human Food, Intentional Adulteration, and Sanitary Transport, relevant to the firm's operations as an LACF and food firm. Discussions also covered consumer complaints, such as "scorched particles" in powder formulas and issues with loose foil seals on liquid product bottles. The company demonstrated efforts to investigate these complaints, attributing particle issues to high-temperature processing and seal problems to a supplier, implementing a new vision cap inspection system. While no formal regulatory actions were mandated, the firm was advised on the importance of timely record review.