FDA 483 - ABC Pharmaceuticals - June 24, 2011

This FDA Form 483 document details observations from an inspection related to **Salmonella Enteritidis (SE)** prevention in a poultry operation.

**Observation 1** notes a failure to conduct environmental testing for SE in a poultry house when a group of laying hens was 40 to 45 weeks of age, as required by approved methods. Specifically: * **Flock 542** in unit 4 (formerly unit 3) was tested on December 6, 2010, when the birds were 51 weeks old, exceeding the specified age range. * **Flock 545** in unit 3 (formerly unit 4) was 47 weeks old at the time of inspection and had not undergone environmental SE testing.

**Observation 2** identifies that the pullet environment was not tested for SE when pullets were 14 to 16 weeks of age. Specifically, pullets from **Flock 545** in unit 3 were tested at 17 weeks of age, which is outside the required 14-16 week window.

These observations indicate deficiencies in the facility's adherence to environmental monitoring protocols for SE at critical stages of poultry development, potentially impacting the quality system and compliance with regulatory requirements for food safety.