FDA EIR - Nestle USA, Inc. - August 14, 2019

An FDA inspection was conducted at Nestle USA, Inc. in Waverly, IA, from August 12 to August 14, 2019. This limited-scope inspection focused on current Good Manufacturing Practices (GMPs) and preventive controls for human food, conducted under regulatory frameworks including DFPG #19-03 and DFPG #18-14, with a specific emphasis on *Salmonella* environmental sampling. While no formal Form FDA 483 was issued, several verbal observations were made.

Key issues included the company's failure to promptly provide a complete food safety plan for review and copying. Additionally, the written recall plan was deficient, lacking specific steps and assigned responsibilities for notifying the public or consignees. Inspectors also identified inconsistencies in the firm's hazard analysis, particularly regarding allergen cross-contamination, which was deemed a significant hazard but lacked an implemented preventive control. Concerns were raised about the review processes for preventive control monitoring and corrective action documentation, as well as adherence to proper usage of detergents and sanitizers in sanitation procedures. Notably, the firm refused to permit photography during the inspection.

In response, Nestle management committed to completing and making their food safety plan, including the recall plan, readily available within three months. They also pledged to correct discrepancies in their hazard analysis and preventive control application, ensure proper review of monitoring and corrective action documentation, and align sanitation procedures with chemical usage instructions, all within a three-month timeframe. Management was reminded of their obligations under the Food, Drug and Cosmetic Act.