FDA 483 - Unknown Company - October 07, 2010

An FDA inspection conducted at Mountain Hollow Farm, LLC, an egg shell producer in Leeds, ME, from October 4-7, 2010, revealed several significant observations regarding its operational compliance. The inspection documented four primary issues. Firstly, eggs intended for processing as table eggs were not consistently held at the required temperature of 45 degrees F or below; recorded temperatures in a cooler reached up to 47.9 F. Secondly, despite monitoring indicating unacceptable rodent activity, appropriate methods for satisfactory rodent control were not effectively implemented, as evidenced by the observation of twenty-three rodents in a poultry house during sampling. Thirdly, the farm failed to maintain proper records documenting compliance with biosecurity measures, specifically regarding personnel biosecurity. Lastly, certain required records, such as the "Moving Tape Fly Count" records, did not include essential identification information like the firm's name and address. These observations highlight areas where Mountain Hollow Farm, LLC needs to implement corrective actions to ensure adherence to food safety and regulatory standards, thereby demonstrating compliance with FDA requirements for egg producers.