FDA 483 - Buitoni Food Company - July 09, 2009

This FDA Form 483 was issued to Nestle USA, Inc., a manufacturer located at 201 Airside Drive, Danville, VA 24540-5616, following an inspection conducted from June 18, 2009, to July 9, 2009. The report was issued to Janice E. Harris, Factory Manager.

Two observations were made during the inspection:

1. **Workmanship of equipment does not allow proper cleaning:** In the "Toll House" brand cookie dough preparation room, gate valves on hoppers used for dry ingredients on production lines 8, 10, 11, and 12 were found to have food contact surfaces that were not easily cleanable. These surfaces were described as rough, pitted, and discolored cast metal alloy. As a result of the investigation, the firm disassembled all such gate valves.

2. **Lack of appropriate design to enable manufacturing systems to be maintained in an appropriate sanitary condition:** Ice build-up was observed surrounding pipes transporting a processing aid to mixers on production lines 8, 10, 11, and 12. Specifically, on line 8, condensate from this ice dripped onto a metal rake used by personnel to scrape cookie dough from the mixer into a dough trough.