FDA EIR - Synlait Milk Limited - August 11, 2023

A US Food and Drug Administration (FDA) inspection of Synlait Milk Limited, an infant formula manufacturer in Auckland, New Zealand, was conducted from August 7-11, 2023. This comprehensive surveillance inspection, carried out under FDA's foreign itinerary, focused on the firm's adherence to Preventive Controls and the Infant Formula Program, specifically referencing 21 CFR Part 106. The inspection reviewed manufacturing and sanitation processes, production records, and quality control systems.

While no FDA Form 483 (Inspectional Observations) was issued, several observations were discussed with management. These included the presence of powder residue on equipment moving ingredient bags, posing a risk of cross-contamination, and apparent bag tag sticker pieces found on surfaces directly contacting the product base, also raising cross-contamination concerns. Furthermore, tear-down records frequently showed seam lengths exceeding maximum allowable measurements. The most significant finding, formally noted, was a failure to ensure that all surfaces contacting ingredients were adequately cleaned and sanitized, a direct violation of 21 CFR 106.30(b). Management committed to making corrections for these issues, with the sanitization deficiency specifically requiring future onsite verification by the FDA.