FDA WARNING_LETTER - Reckitt/Mead Johnson Nutrition - January 09, 2023

The FDA inspected two powdered infant formula manufacturing facilities, Zeeland, MI (February 2023) and Wanamingo, MN (November 2022-January 2023), identifying significant violations of 21 C.F.R. Part 106, the Infant Formula Rule. The firm failed to establish adequate process controls to prevent microbiological adulteration (21 C.F.R. § 106.55(a)). At Zeeland, Cronobacter sakazakii was found in finished product, with an inadequate root cause analysis that overlooked Whole Genome Sequencing, other contamination sources like leaks and spilled product, and relied on unproven "product flush" remediation. Environmental Cronobacter detections in high hygiene zones also lacked thorough investigation and documentation. Multiple water events were observed, creating conditions favorable for pathogen growth, with insufficient reporting. At Wanamingo, a C. sakazakii positive finished product led to reliance on a third-party's root cause analysis, resulting in the release of adulterated product. Environmental monitoring also showed unaddressed Cronobacter spp. detections. Additionally, the firm failed to ensure equipment was of appropriate design for cleaning (21 C.F.R. § 106.30), evidenced by excessive powder spillage at Zeeland. Crucially, the firm failed to promptly notify FDA when adulterated infant formula left its control (21 C.F.R. § 106.150), occurring at both facilities. The FDA requires a response within fifteen working days detailing corrective actions, with potential legal action if not addressed.