FDA 483 - Hillandale Farms Conn, LLC - October 21, 2010

This FDA Form 483 was issued to Dorothy Egg Farms, LLC, a producer located at Plant 1, 271 Turkey Lane, Winthrop, ME 04364. The inspection was conducted from October 18, 2010, to October 21, 2010. John C. Lough, Owner, was the individual to whom the report was issued.

Two observations were made:

1. **Failure to maintain records documenting compliance with biosecurity measures:** The firm's "Dorothy Egg / (b)(4) Bio-security Plan" (Created 05/01/2010, Last Updated 09/17/2010) states that equipment used across multiple barns "will be cleaned and disinfected between barns." However, there was no documentation of cleaning and disinfection for the skid steer loader used for weekly manure removal across multiple barns.

2. **Eggs not maintained at or below 45 degrees F beginning 36 hours after time of lay:** A review of the "Critical Limit Monitoring Report" for Plant # 1021, Winthrop Maine, showed that the ambient temperature of Egg Cooler (b)(4) and Egg Cooler (b)(4) exceeded 45 degrees F on multiple dates in September 2010. Specifically, Egg Cooler (b)(4) recorded temperatures of 48