FDA 483 - Abbott Laboratories - October 22, 2010

An FDA 483 inspection revealed significant deviations at a food manufacturing facility concerning contamination control and pest exclusion. The primary violation identified was the failure to manufacture foods under conditions necessary to minimize contamination, specifically from small beetles, identified as warehouse beetles.The investigation determined that defective design elements in the facility were the root cause for beetle ingress into the product stream. Specifically, hopper vent systems, including vent manifolds, dust collectors, and waste bag-off stations, were periodically opened for cleaning, creating opportunities for beetles to enter the otherwise closed product contact system. The temporary removal of collection bins further exposed the system to a pest-present environment. Additionally, a diverter valve safety guard in the basement was found to have beetles and escaped product inside its sealed, opaque shroud. This design prevented proper inspection, allowing valve failure and pest infiltration to go undetected.Moreover, the facility failed to implement effective measures to exclude pests from processing areas. A review of pest control audit records from January 2007 through September 2010 consistently documented the widespread presence of Warehouse Beetles and Flour Beetles across multiple buildings. Insect Light Traps repeatedly identified warehouse beetles, and service comments indicated high infestation levels, with larvae found under traps.These findings highlight a critical need for the company to implement comprehensive corrective actions to rectify design deficiencies, enhance pest management protocols, and ensure compliance with regulatory requirements for food safety standards.