FDA EIR - Gerber Products Company - September 15, 2017

An FDA inspection of Gerber Products Company dba Nestle Nutrition-Eau Claire took place from September 11-15, 2017. The inspection primarily focused on the aseptic processing of medical foods, specifically Peptamen Jr., and reviewed records related to Gerber Good Start liquid infant formula manufacturing. The regulatory framework for this comprehensive evaluation included FDA guidance documents CP7321.006, CP7321.002, CP7303.803A, and the modified Current Good Manufacturing Practice (cGMP) provisions outlined in 21 CFR Part 117.

While no FDA Form 483 was issued, several observations were discussed with company management. Key issues included critical control point monitoring devices on aseptic fill and seal machines being calibrated at only a single data point, rather than multiple points. There was also an inability to fully document the actual temperatures or pressures when critical control point alarms were activated during challenges. Additionally, white insulation beads were observed on the floor of the CPL Processing Area, originating from a gap in a wall sleeve. Finally, a Master Sanitation Schedule for the week of May 7, 2017, was not properly reviewed, initialed, and dated prior to the release of products processed on that date.

Management responded promptly to the findings. Immediate corrective actions were taken to repair the wall sleeve gap and clean and sanitize the affected area. The company also committed to implementing future corrective actions to address the remaining observations, ensuring adherence to regulatory requirements for their infant formula and medical food products. During the inspection, three product samples were collected for nutritional, microbiological, and label analysis.