FDA EIR - Mead Johnson & Company, LLC - May 04, 2018

A surveillance inspection of Mead Johnson Nutrition's infant formula manufacturing facility in Zeeland, MI, was conducted by the FDA from April 30 to May 4, 2018. This inspection, carried out under the Infant Formula Program, aimed to assess operations across its Zeeland Specialty Products (ZSP) and Zeeland Integrated Powder Processing (ZIPP) facilities, and review consumer complaints. The inspection found no significant deficiencies, and no FDA Form 483 (Inspectional Observations) was issued. This indicates a positive change from a previous directed inspection (October-December 2017), which resulted in two observations regarding environmental contamination by Cronobacter sakazakii and internal cracks in ZIPP dryers. During the current visit, the FDA verified that Mead Johnson Nutrition had implemented several corrective actions for these prior issues. These included enhanced sanitation procedures for specific equipment, increased cleaning frequencies, structural improvements like new flooring and sealing water infiltration points, and regular inspections for dryer cracks, with a comprehensive internal examination scheduled. A minor procedural issue regarding the method for opening bulk ingredient bags in the ZSP blending area was discussed, where the firm promptly revised its procedure to prevent external bag material from contacting the product. Overall, the company demonstrated successful remediation of previously identified concerns, ensuring adherence to infant formula manufacturing standards.