Setton International Foods, Inc. – FDA 483, Apr 8, 2009

From March 31 to April 8, 2009, the FDA inspected Setton International Foods, Inc., a manufacturer and repacker located at 85 Austin Blvd, Commack, NY. The inspection revealed six observations regarding sanitation and hygiene practices.

Observation 1 noted a failure to conduct cleaning and sanitizing operations to protect against food contamination. The firm's "Equipment Cleaning Procedures" SOP was inadequate, only calling for sanitization without a prior wash step. Employees were observed performing only a sanitization step, and the "Master Cleaning Schedule Log" did not include all items from the SOP. Additionally, the firm lacked sanitizer test strips to verify chlorine solution concentration.

Observation 3 detailed employees failing to wash hands thoroughly when soiled or contaminated. An employee was seen handling a box cutter, then returning to packing ready-to-eat sour bears without changing gloves or washing hands. Two employees touched food-contact surfaces of lids.

Observation 4 highlighted a lack of adequate handwashing facilities. The only sinks were in employee bathrooms, with none in the Packaging, Panning, Organic, or Roasting Rooms where ready-to-eat foods are processed.

Observation 5 cited a failure to wear appropriate hair restraints. Employees and a manager with facial hair were observed in processing areas without restraints. Hairnets were also worn ineffectively, not covering all hair.

Finally, Observation 6 noted a failure to provide safety-type lighting fixtures over exposed food,