FDA EIR - Kendal Nutricare Ltd. - June 23, 2023

An initial FDA inspection of Kendal Nutricare Ltd., a manufacturer of non-exempt infant formula in Kendal, GB, was conducted from June 19 to June 23, 2023. This pre-announced, full-scope preventive controls inspection was carried out under the US FDA's foreign inspection itinerary, covering the firm's manufacturing processes, good manufacturing practices (cGMPs), and adherence to production controls for Kendamil Organic Infant Formula. The firm is currently under FDA Enforcement Discretion.

While no formal FDA Form 483 (Inspectional Observations) was issued, seven significant items were discussed with management. These included concerns regarding the design and maintenance of equipment and utensils for adequate cleaning, insufficient plant repair, and deficiencies in personnel practices. Additionally, toilet facilities lacked hot and cold water with appropriate drying methods. GMP audits were identified as not accurately reflecting actual conditions, the CIP cleaning alarm system had not been routinely challenged, and pasteurizer validation parameters were unclearly defined.

The firm committed to implementing corrective actions. The inspection concluded with a "No Action Indicated" classification, with a recommendation for a routine re-inspection on a work plan basis.