FDA 483 - Kendal Nutricare Ltd. - June 21, 2024

Kendal Nutricare Ltd., an infant formula manufacturer in Kendal, United Kingdom, was cited for significant deficiencies during an FDA inspection. Observations included inadequate process controls for microbial contamination, unsanitary facility conditions, insufficient testing of raw materials, and improper temperature monitoring in thermal processing. These issues indicate a lack of control over critical manufacturing processes and facility maintenance, posing potential risks to product quality and safety.