FDA EIR - Unknown Company - September 18, 2009

New Era Foods, LLC underwent an FDA compliance follow-up inspection from September 14-18, 2009, as a low-acid canned food manufacturer. This inspection followed a critical period for the company. A previous FDA inspection (late 2007-early 2008) identified severe Good Manufacturing Practice (GMP) and Low Acid Canned Food (LACF) deficiencies. Key issues included failures in managing process deviations, inadequate evaluation of defective product lots, absence of temperature distribution studies for retort systems, and the alarming detection of Clostridium botulinum spores in finished product and cooling water. Other significant problems involved unqualified can seam teardowns resulting in loose seams, improper cooling water treatment, and inadequate retort traffic control, leading to commingling of cooked and uncooked products. These violations led to an FDA 483, multiple voluntary recalls, state product seizure, and the imposition of an Emergency Permit, prohibiting interstate commerce. During the 2009 follow-up, the firm, under new ownership and management, had notably addressed all prior FDA 483 observations and discussion points, with significant capital improvements to processing and water systems. No new FDA 483 was issued. The inspection confirmed that critical processing factors and container integrity were met for current operations. However, an unprotected underground suction potential in the water supply remained a discussion item, which management committed to rectifying. The company continues to operate under its Emergency Permit.