FDA 483 - Pressure Safe LLC - December 07, 2017

An FDA inspection of Pressure Safe, LLC, a food manufacturer in Wood Village, OR, revealed four repeat observations related to deficiencies in their HACCP plan and its implementation for high-pressure processed beverages. The firm's HACCP plan failed to list all food hazards and critical limits, lacked validation for a 5-log reduction of pertinent microorganisms, and critical control point monitoring records were not reviewed within the required timeframe. These issues indicate significant concerns with the firm's food safety controls.