FDA 483 - Estrella Family Creamery, LLC - September 10, 2010

During an FDA inspection on September 1, 2010, a food manufacturing facility was cited for multiple violations. The facility failed to manufacture and store foods under conditions minimizing microbial growth and contamination. Specifically, cheese wheels in Cave 1 were stored in direct contact with rough-cut, undressed lumber shelving showing product residue, and a leaking cooler water line dripped near exposed cheese.

Precautions against contamination were inadequate. The owner was observed sampling cheese with a trier, replacing the plug, and wiping the trier with a rag without washing or sanitizing. Handwashing was not observed before or after this process. Employees did not wash hands thoroughly after leaving workstations or when hands became soiled; the owner handled unwrapped ready-to-eat cheese multiple times without handwashing. Suitable outer garments were not worn, as the owner carried cheese wheels against street clothing.

Measures to protect against metal and extraneous material inclusion were insufficient. Cheese wheels in Cave 1 were stored on splintering wood shelving with loose wood particles, and loose nuts, bolts, tacks, and a hand wrench were observed on shelves in direct contact with product. Equipment materials and workmanship did not allow proper cleaning; cheese press pipes had peeling paint and taped handles, and press weights had heavy rust. Rough-cut, undressed lumber shelving was used for exposed cheese.

Finally, buildings and fixtures were not maintained in a sanitary condition. Soiled surfaces with handprints, smudges, or splash residue were