FDA EIR - Mead Johnson & Company, LLC - August 09, 2018

An FDA inspection of Mead Johnson Nutrition's Evansville, Indiana facility occurred from August 6 to August 9, 2018. This routine surveillance, conducted under the Infant Formula Program (CP7321.006), Domestic Acidified and Low-Acid Canned Foods Program (CP7303.803A), and Modernized GMP Inspections (PAC 03014), centered on the aseptic processing of infant formulas. The inspection led to a FDA Form 483 with two observations. First, the cold storage for final infant formula was not consistently maintained below 4.4°C for a defined period, with insufficient scientific data specific to infant formula to support current practices (21 CFR 106.30(e)(2)(ii)). Second, the high-temperature alarms on cold storage tanks lacked routine validation at their set-point, and the alarm set-point itself was non-compliant with infant formula regulations (21 CFR 106.30(e)(3)(ii)(C)). Additionally, five significant items were verbally discussed: discrepancies in temperature recording on an aseptic line, initial review of Low-Acid Canned Food records by System Operators instead of management, a lack of routine challenging for critical factor alarms, inadequate manual documentation of critical factors on an aseptic line between sterilization and production, and the offsite storage of annual quality control and GMP audit procedures, which should be available at the facility per 21 CFR Part 106. Management committed to providing a written response to the FDA 483 observations within 15 days and reviewing the verbally discussed issues. FDA recommended specific scientific data for infant formula cold storage, routine alarm validation, management-level record review, manual critical factor documentation, and onsite availability of audit procedures.