Kendal Nutricare Ltd. – FDA EIR, Jun 21, 2024

Kendal Nutricare Ltd., a manufacturer of Kendamil infant formula products, was subject to a pre-announced FDA surveillance inspection from June 17 to June 21, 2024. The inspection revealed significant deviations from regulatory requirements for infant formula manufacturing, which were documented in an FDA-483 form. Key issues included a lack of established process controls to prevent microbial adulteration of infant formula, failure to maintain sanitary conditions in manufacturing facilities, insufficient frequency of water testing to comply with EPA drinking water regulations, and inadequate temperature monitoring in thermal processing equipment.

Commercial Director Mr. William McMahon was verbally warned that these deviations could result in Kendamil products being refused or detained upon entry into the United States. He was encouraged to submit a written corrective action plan within 15 business days, which he committed to providing. The company also made an immediate voluntary correction by removing an unsubstantiated “FDA Certified” claim from its website during the inspection. The FDA's follow-up classification is "Voluntary Action Indicated," requiring verification of these corrective actions during an upcoming assignment.