Tiny Greens – FDA 483, Jan 28, 2011

The FDA Form 483 details numerous observations at a production facility, highlighting significant sanitation and operational deficiencies. The facility has multiple entrances, all serving as pathways for personnel and equipment into production areas.

Key violations include: - **Cross-Contamination Pathways:** Employees were observed moving between a compost pile (site of Salmonella 4, 5, 12, i outbreak strain) and production areas without changing clothing or sanitizing boots. Runoff from the compost pile was pooling near a greenhouse entrance. - **Uncontrolled Access/Environment:** Employees used the greenhouse (containing plant material, soil, overhead irrigation) as a break area while in production attire. Entrances were near exterior bird harborage and a fountain, with an amphibian/reptile in the reception area, all providing potential contamination routes to production. - **Inadequate Sanitation Practices:** Foot baths were found empty or with inconsistent sanitizer strength. Seed antimicrobial treatment methods were not equivalent to recommended standards, lacking proper contact time, strength verification, and adherence to product labeling. - **Personnel Hygiene Issues:** Employees handled production waste and returned to production without changing; used restrooms and returned to production with aprons on; handled personal cell phones without subsequent hand sanitation. - **Poor Equipment and Facility Maintenance:** Equipment was cleaned near open sprout trays, causing splashing. Employee lunches and raw bacon were stored in the same cooler as finished sprouts. Aprons with duct tape were used as food contact surfaces. Germination drum