FDA 483 - Sunland, Inc. - March 10, 2009

This FDA Form 483 documents observations from an inspection, highlighting significant deficiencies in manufacturing controls and sanitation at a food production facility. The primary operation involves the processing and packaging of peanut butter, specifically "ready-to-eat Creamy Peanut Butter."

Several violations were noted, indicating a failure to minimize microbial contamination and ensure product safety. A key observation involved an employee on the bulk peanut fill line handling the outside of 40 lb finished product buckets and then touching the inside rim with the same gloved fingers. Another employee on the same line was observed operating a fill switch and then placing part of the same hand inside containers just prior to filling. Both of these employee hygiene issues are repeat observations from the previous inspection.

Further issues included equipment contamination: a filler leaked peanut butter from pistons and gaskets onto a balance tank, with a cardboard box placed underneath to catch the leaking product, which was nearly half full. This leakage is also a repeat observation. Additionally, product residues were observed on a large mill (used on the "New Line") due to discharge from a pressure relief valve. A basic sanitation deficiency was also noted: the hand wash sink in the grinder room lacked soap and paper towels, which is another repeat observation.

These findings indicate a failure to adhere to regulatory requirements for manufacturing foods under conditions and controls necessary to minimize contamination, and a failure to take all reasonable precautions to prevent contamination from production procedures. The repeat nature of several observations suggests persistent issues with quality systems and operational