FDA 483 - Sunny Yolk Farms, Inc. - August 24, 2011

This FDA Form 483 document outlines observations made during an inspection related to **_Salmonella Enteritidis (SE)_** prevention. The facility's written SE prevention plan is not fully implemented and followed.

**Key Observations:**

* **Footbath Placement:** The plan states footbaths are to be placed in high-traffic areas and between sections. However, dry footbaths were observed only at the entrance to the office and the entrance to the processing plant. This indicates a failure to fully implement the specified footbath placement strategy. * **Cross-Contamination Protection:** Practices to protect against cross-contamination when employees and equipment are moved between poultry houses are not adequately maintained. * **Biosecurity for SE Positive Houses:** The SE prevention plan does not address biosecurity measures specifically for situations where a poultry house tests positive for SE. This is a critical gap in preventing the spread of contamination. * **Foot Powder Documentation:** There is no documentation maintained regarding the frequency of changing foot powders or the criteria dictating when foot powder changes should occur. This lack of documentation suggests insufficient control and monitoring of a key biosecurity measure.

**Regulatory Citations and Implications:**

The observations indicate deficiencies in the facility's quality system and manufacturing practices related to SE prevention. The lack of full implementation of the written plan, inadequate cross-contamination controls, and insufficient biosecurity protocols for SE-positive houses suggest potential risks to product