FDA 483 - Peanut Corporation of America (PCA) - February 26, 2009

During an FDA inspection from February 4 to February 26, 2009, Peanut Corporation of America (PCA) in Plainview, TX, was cited for numerous significant deficiencies under food safety regulations. Key observations, detailed in a Form FDA 483, highlighted critical failures in sanitation and quality control practices. The inspection revealed extensive pest issues, with evidence of rodent activity, including dead mice and excreta, in processing areas and false ceilings, along with unsealed entry points. Furthermore, the air-makeup system's filters were found contaminated with debris, potentially drawing contaminants from pest-infested areas into food processing environments. Observations also noted inadequate cleaning of both food-contact and non-food-contact surfaces, with visible accumulations of peanut residue on various equipment. Structural integrity was compromised by active roof leaks allowing water to drip into processing and storage areas. The firm also failed to properly segregate recalled product from other finished goods, risking inadvertent shipment. Critically, PCA lacked documented assurance that raw peanut lots testing positive for aflatoxin were reconditioned and re-tested to meet FDA safety standards before being used in products for human consumption. These observations indicate a need for PCA to implement comprehensive corrective actions to address the identified sanitation, pest control, facility maintenance, and raw material control deficiencies to ensure product safety and regulatory compliance.