FDA EIR - Pressure Safe LLC - May 29, 2019

A comprehensive FDA compliance follow-up inspection of Pressure Safe, LLC in Wood Village, OR, was conducted from May 7-29, 2019. The inspection, performed under the Juice HACCP Inspection Program and Modernized GMP regulations, focused on the company's high-pressure processing operations for bottled juice beverages. Several significant issues, some repeating from previous inspections, were identified and documented on Form FDA 483.

The main violations included the failure to provide adequate validation that critical limits for high-pressure processing of certain juice products consistently achieve a five-log reduction of pertinent microorganisms. Additionally, the company's HACCP plan listed a critical limit for juice pH that did not align with a customer's stricter requirements, and critical control point monitoring records for pH at receiving were not reviewed within the required seven-day period.

In response, Pressure Safe's management stated they had ceased processing unvalidated juice products and committed to revising their HACCP plan to align pH critical limits. They also pledged immediate compliance with the seven-day record review requirement. The firm indicated they would provide a written response to the FDA 483 within 15 business days. The FDA also advised the firm to establish comprehensive written agreements with juice customers to clarify shared responsibilities regarding validation, process changes, deviations, and recalls.