FDA EIR - Unknown Company - September 18, 2009

A follow-up FDA inspection of New Era Foods, LLC, a low-acid canned food manufacturer, was conducted from September 14-18, 2009. This inspection aimed to verify corrections following a severe 2007-2008 inspection that identified critical Good Manufacturing Practice and Low Acid Canned Food deficiencies. Previous issues included improper handling of process deviations, inadequate evaluation of defective lots, absence of temperature distribution studies, detection of Clostridium botulinum spores in product and cooling water, poor container integrity, inadequate cooling water treatment, and insufficient retort traffic control. These led to an FDA 483, voluntary recalls, product seizure, and the firm operating under an Emergency Permit. During the 2009 inspection, the company, under new ownership and management, demonstrated significant improvements. All prior FDA 483 observations were reportedly corrected, supported by substantial capital investments in plant upgrades, thermal processing systems, and container integrity testing. The firm's water supply system also underwent extensive improvements across all four wells, addressing previous contamination risks. No process deviations were identified in the reviewed 2009 production records, and container integrity met specifications. While a 483 was not issued, a discussion item regarding the potential for an unprotected underground suction event in the water supply system was noted, with management planning pump replacement. The firm continues to operate under an Emergency Permit.