FDA EIR - Burnette Foods, Inc - September 18, 2009

An FDA compliance follow-up inspection was conducted at New Era Foods, LLC, a low acid canned food manufacturer, from September 14-18, 2009. This inspection aimed to assess corrections made since a prior severe inspection in 2007-2008, which identified numerous critical deficiencies under FDA's regulatory framework for Low Acid Canned Foods. The previous inspection revealed serious issues including inadequate process deviation handling, failure to evaluate defective lots, lack of temperature distribution studies on retort systems, and the detection of viable Clostridium botulinum spores in products and cooling water. Other violations included critical water system deficiencies, unqualified personnel conducting can seam teardowns resulting in loose seams, poor retort traffic control, and missing or inadequate can coding. These led to an FDA Form 483, a demand for records, four voluntary recalls, state product seizure, and the issuance of an Emergency Permit prohibiting interstate shipment. During the 2009 follow-up, under new ownership and revised management, all previous FDA 483 observations and discussion items appeared to have been corrected. The company invested significantly in capital improvements across the processing plant, thermal processing systems, container integrity equipment, and water supply. The inspection observed current green bean processing, confirming critical factors were met and can seams adhered to specifications. While no new FDA Form 483 was issued, several discussion items were addressed with management.