FDA EIR - Mead Johnson & Company, LLC - March 21, 2019

The FDA conducted a comprehensive surveillance inspection of Mead Johnson Nutrition's Zeeland, MI facility from March 18-21, 2019. The inspection, part of the Infant Formula and Medical Foods Programs, was conducted under regulatory frameworks including 21 CFR Part 117 (Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods) and related Compliance Programs. The facility manufactures powder infant formula and medical foods.

Key issues discussed with management included the firm's environmental swabbing program for Cronobacter spp., where retesting for initial positives did not always lead to further action if negative. Inspectors observed a partial pallet of resealed activated carbon improperly staged near base formula. There was also a notable reoccurrence of internal cracks, often identified as previous weld repairs, in the ZSP and ZIPP dryer systems. Additionally, Master Batch Records did not consistently document supervisor notification when certain tank temperatures fell below required minimums, even though automated alarms were stated to be in place.

The inspection covered various operational aspects like cGMPs, complaints, recalls, and quality control. Samples of finished products were collected for analysis. The document indicates discussions with management regarding these observations, alongside some voluntary corrections implemented by the firm, to ensure compliance with professional manufacturing and quality standards.