FDA 483 - Malcolm Sonnen - May 06, 2011

The FDA Form 483 documents observations from an inspection of a firm producing shell eggs for the table market. The firm was cited for not having a written *Salmonella Enteritidis* (SE) prevention plan specific to the farm where eggs are produced, and for failing to implement an SE Prevention Plan from July 9, 2010, to November 18, 2010, while producing shell eggs. The current SE Prevention Plan on file is dated November 19, 2010.

Additionally, the firm failed to implement appropriate methods for satisfactory fly control when monitoring indicated unacceptable fly activity. Specifically, the SE Prevention Plan's requirement to replace redacted fly traps at redacted intervals was not met. Fly monitoring records showed average fly counts exceeding the stated threshold of redacted per redacted on multiple occasions between October 5, 2010, and February 27, 2011, with counts ranging from 245 to 670.

Finally, the firm did not prevent stray animals from entering poultry houses. Several locations along the roof eaves on the North Side of the Poultry House lacked a barrier or had redacted, allowing potential entry.