FDA EIR - Mead Johnson & Company, LLC - August 16, 2017

An FDA routine surveillance inspection of Mead Johnson Nutrition's Evansville, IN facility was conducted from August 8-16, 2017. The inspection focused on the infant formula manufacturer's liquid concentrate, ready-to-use (RTU), and powder formula operations, specifically reviewing the new aseptic processing line for 32oz plastic bottles and the powder blending (BIBBIT) operations. The inspection was performed under Compliance Programs for Infant Formula (CP 7321.006) and Domestic Acidified and Low-Acid Canned Foods (CP 7303.803A), covering regulations such as 21 CFR 106, 107, and 110. A key outcome of this inspection was that no FDA Form 483, indicating inspectional observations or violations, was issued. This suggests that the facility was found to be operating in compliance with regulatory standards during this period. The inspection included a review of batch records, validation documents for the new aseptic line, process deviations, out-of-specifications, product rejects, recalls, pest control, and internal audit procedures. While various process deviations (e.g., reel stoppage, low flow readings) and a high volume of consumer complaints (e.g., product appearance, taste, outdated product, foreign objects) were documented and reviewed, the FDA investigator noted that all complaints logged in the FDA FACTS database appeared to be adequately investigated by the firm. No specific regulatory actions were required as a direct result of this inspection.