FDA EIR - Nestle Healthcare Nutrition Inc. - September 14, 2018

An FDA inspection of Gerber Products Company dba Nestle Nutrition-Eau Claire was conducted from September 10-14, 2018, under the HAFW1 FY18 work plan. The inspection assessed compliance with regulatory frameworks including the Infant Formula Program (7321.006), Medical Foods Program (7321.002), Domestic Acidified and Low Acid Canned Foods Program (7303.803A), and the modernized Current Good Manufacturing Practice (cGMP) provisions in 21 CFR Part 117. While no formal FDA 483 observations were issued during this visit, several points requiring attention were discussed with facility management. Key issues highlighted from a previous inspection included critical control point monitoring devices on aseptic processing machines being calibrated at only one data point, an inability to fully document actual alarm activation temperatures and pressures for these devices, and a master sanitation schedule not being reviewed and dated prior to product release in May 2017. During the current inspection, findings included a whey protein concentrate powder spill in the South Warehouse and the presence of a flying insect in the packaging room. Management took immediate corrective action for the insulation bead gap from the previous inspection and committed to future actions to address the calibration, documentation, and sanitation schedule review deficiencies. They also promised corrections for the powder spill and insect observation.