FDA EIR - Pressure Safe LLC - December 07, 2017

An FDA inspection of Pressure Safe, LLC in Wood Village, OR, conducted from November 27 to December 7, 2017, identified significant deficiencies related to the company's Hazard Analysis and Critical Control Point (HACCP) plan. These issues were repeat observations from a previous inspection. The primary violations concerned the omission of essential food safety hazards and critical limits within the company's HACCP plan, which is governed by 21 CFR 120 (Juice HACCP regulations). Specifically, the HACCP plan failed to identify Clostridium botulinum as a reasonably likely food hazard for low-acid juices and lacked a critical control point at the receiving step for pH verification. Additionally, the plan did not explicitly state critical limits for the high-pressure processing step, instead referencing customer HACCP plans. The inspection also revealed that the firm routinely failed to achieve the required high-pressure processing critical limits for certain products. In response, Pressure Safe, LLC initiated voluntary corrective actions. The company committed to revising its HACCP plan to include a critical control point for Clostridium botulinum at the receiving step, with a critical limit of pH 4.6 or lower for incoming juices, verified by in-house testing. They also secured agreements with suppliers to ensure juices meet this pH requirement. Furthermore, the firm agreed to explicitly list all validated critical limits for high-pressure processing within its own HACCP plan, setting more stringent parameters to account for equipment variability and ensure compliance with minimum pressure requirements during processing cycles. Implementation of these changes, including equipment acquisition and staff training, was planned for completion within a specified timeframe.