FDA EIR - Mead Johnson & Company, LLC - August 21, 2015

A routine FDA surveillance inspection was conducted at Mead Johnson Nutrition in Evansville, IN, from August 17-21, 2015. The inspection focused on the manufacturing of liquid concentrate, ready-to-use, and powder infant formula, operating under the Infant Formula and Domestic Acidified and Low-Acid Canned Foods Programs. Notably, the inspection concluded without the issuance of an FDA Form 483, indicating no significant regulatory violations requiring immediate formal action.

However, two operational items were discussed with management. These included concerns regarding the ability to remove unprocessed and processed 32oz bottles from an air over pressure retort line and the presence of brown residue in a neutralization tank following a clean-in-place procedure. The firm also reported 10,210 consumer complaints, primarily related to product appearance (specks/particles) and infant reactions (spitting up, fussiness), which were generally attributed to burnt whey particles during processing. Additionally, 20 incidents of out-of-specification product were thoroughly investigated, with all batches subsequently released without restrictions. Mead Johnson maintains a comprehensive stability program and robust recall procedures, having experienced no recalls in the preceding year. The inspection highlighted the company's commitment to quality control and adherence to regulatory standards for infant formula production.