FDA 483 - Berkshire Layers - April 06, 2011

On April 5-6, 2011, the FDA inspected Berkshire Layers, an egg producer located at 3304 Mountain Road, Hamburg, PA 19526. The inspection revealed three observations regarding record-keeping deficiencies related to refrigeration requirements.

Observation 1 noted that the firm failed to maintain records documenting compliance with refrigeration requirements. Specifically, egg cooler temperatures were not recorded on the temperature log for the period of August 15, 2010, to September 4, 2010.

Observation 2 indicated that required records did not include the time of the activity they reflected. The temperature log, in particular, lacked the time at which temperatures were taken.

Observation 3 stated that all required records did not have the signature or initials of the person performing the operation or creating the record. The temperature log was not signed or initialed by the individual recording the temperature at the time of recording.

The FDA 483 form was issued to Christopher M. Smith, Manager, on April 6, 2011.