FDA EIR - Prinova US LLC dba Prinova Particle Technologies - November 19, 2019

Lakeshore Technologies LLC, a food ingredient manufacturer and repacker, underwent a comprehensive current Good Manufacturing Practices (CGMP) and limited-scope Preventive Controls for Human Food (PCHF) surveillance inspection on November 19, 2019. This inspection, conducted under the regulatory framework of CP7303.040, focused on preventive controls and sanitary operations. While no FDA Form 483 (Inspectional Observations) was issued, the inspection revealed two primary concerns that were verbally discussed with management. First, an atmospheric vacuum breaker was noted on a hose with a downstream valve near warehouse doors, used for filling hi-low batteries, raising potential issues. Second, the facility's floors in both non-allergen and allergen processing areas, particularly in the Repacking and Mill sections, showed significant wear with exposed aggregate. In response, management committed to immediate action. For the vacuum breaker, they pledged to contact a plumber to evaluate the backflow device and implement necessary corrections. Regarding the worn flooring, management acknowledged the issue, referencing an existing work order, and assured the inspector that repairs for all affected facility floors were slated for completion by the end of 2020, with some areas by the end of the first quarter of 2020. The firm's training and environmental monitoring programs were reviewed and found to be in place.