FDA 483 - Cal-Maine Foods - June 15, 2011

On June 14-15, 2011, FDA investigators Christian L. Witkovskie and Luckner Jean-Marie conducted an inspection of Cal-Maine Foods, a farm located at 11500 State Route 181N, Bremen, KY 42325. The inspection resulted in four observations documented on Form FDA 483, issued to Charles R. Gossett, General Manager.

Observation 1 noted that stray animals were not prevented from entering poultry houses. Specifically, live mice were observed in House #1 (three on the floor/ledge near the water, one on the ledge at the rear) and House #4 (two mice 50' from the front).

Observation 2 stated that data and information reflecting compliance activities did not indicate actual values. The Visual Rodent Evaluation Forms for all houses from July 2010 to present did not show evidence of rodent activity, despite live mice being observed during the inspection.

Observation 3 indicated that required records did not include the time of the activity they reflected. This applied to the Environmental Sampling Log, Cleaning and Disinfection Inspection Form, Footwear Station Service Report, Visual Rodent Evaluation Form, and Rodent Indexing Record.

Observation 4 found that required records did not include the farm's location. This omission was noted on the Cleaning and Disinfection Inspection Form, Visual Rodent Evaluation Form, Rodent Indexing Record,