Synlait Milk Limited – FDA EIR, Aug 18, 2023

An FDA inspection of Synlait Milk Limited's Pokeno facility, a manufacturer of infant formula pre-mix, was conducted from August 14-18, 2023. This initial full-scope inspection, performed under US Food and Drug Administration (FDA) regulations, including 21 CFR Part 106 for Infant Formula and 21 CFR Part 117 for Preventive Controls, aimed to ensure compliance for products exported to the United States. While no FDA Form 483 Inspectional Observations were issued, several significant issues were discussed with management. These included failing to adequately clean and sanitize surfaces that contacted in-process materials after a system blockage, and lacking documentation of these cleaning procedures. The inspection also identified inadequate regular maintenance of equipment, specifically an omission in the internal dryer inspection. Additionally, equipment design issues were noted, such as pooled water on the dryer platform, hindering proper sanitation. A critical observation concerned the absence of appropriate backflow prevention devices on six hoses in sensitive manufacturing areas, posing a risk of contamination to water used in infant formula production. Synlait Milk Limited committed to immediate corrections for all identified concerns, including updating procedures, employee training, and addressing infrastructure deficiencies like drainage and backflow prevention, with a promise of written response.