FDA 483 - Quesos Mi Pueblito, LLC / Firm is OOB - August 26, 2009

The FDA Form 483 details numerous violations at a cheese production facility. Plumbing issues include a deep pit in the cheese production room with a sewer vent pipe expressing gases, a broken sewer vent pipe near a hand wash sink, a leaking foot actuator valve on a hand wash sink, and condensed water from an ice machine draining onto the production floor near the raw milk tank. An open drain pipe was observed near an inoperable hand wash sink, and a garden hose used for in-process water and cleaning was connected to an unprotected, leaking water line sealed with plastic wrap. Floor drains in the finished product refrigerator and outside the employee restroom were clogged and lacked protective screening.

Facility maintenance deficiencies include a deep pit in the production room with stagnant water, damaged and missing ceiling tiles over hard cheese and salt bags, respectively.

Temperature control issues were noted, with the firm's refrigerator thermometer consistently reading significantly lower than a calibrated FDA thermometer (e.g., 44°F vs. 55°F, 36°F vs. 50°F, 32°F vs. 44-46°F). Consequently, various cheese products (Queso Cotija, Queso Fresco, Queso Oaxaca, Queso Requeson, mozzarella curd) were stored in the production room walk-in refrigerator at temperatures ranging from 44°F to 55°F, failing to prevent the growth of undesirable microorganisms.