FDA 483 - Jeni's Splendid Ice Creams - June 27, 2008

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in pest control, facility maintenance, employee hygiene, and sanitation practices.

**Pest Control and Facility Integrity:** The facility failed to exclude pests effectively. Rodent excreta pellets (REPs) were extensively observed: 3-4 REPs/foot along a six-foot oven wall in the production area, 22 REPs on Styrofoam shipping components, 18 REPs in a box of unlabeled fig almond paste jars, and numerous REPs in floor/wall junctures throughout storage areas. A live rodent was found on a glue trap, and 2-3 insects were on each of three glue boards in storage. The facility also lacked adequate screening against pests, with numerous unscreened holes in exterior walls (e.g., 1/2" gaps under garage bay doors, which were left open for over an hour; 4" and 1.5" unscreened holes, a 1/4" gap around a pipe, and an 18"x18" exhaust fan in the east wall; four holes ranging from 2" to 16"x24" in the west concrete wall).

**Employee Hygiene and Practices:** Employees in contact with food-contact surfaces and packaging did not maintain adequate personal cleanliness. An employee scratched his head with bare hands and returned to preparing ice cream mix without washing hands. Other