FDA 483 - perrigo florida inc - February 14, 2006

On February 14, 2006, the FDA issued a Form 483 to Unico Holdings, Inc., a manufacturer located in Lake Worth, FL, following an inspection from February 6-14, 2006. The inspection revealed 19 observations related to food and drug manufacturing practices.

Key violations include: * **Inadequate Training:** Food handlers and supervisors lacked appropriate training in food handling and protection principles. Operators were unfamiliar with machine settings and functions, and personnel could not explain pasteurizer operations or PSI gauge functions, which were critical for validation and flow assessment. * **Contamination Risks:** * **Mechanical Issues:** Production equipment (filler, capper, tamper-evident band applicator) was not maintained per manufacturer's recommendations, leading to inconsistent fills, uncapped bottles, and missing tamper-evident bands. Pasteurization parameters (time, temperature, flow rate) could not be assessed due to uncalibrated gauges and lack of flow meters. A bottle inverter's vacuum system was inoperable, and the filler machine consistently overfilled, spilling product. Air supply for production lines was inadequate. * **Production Procedures:** Standard procedure involved emptying solution directly onto the floor near production lines, causing splashing and tracking of solution throughout the facility. Labels were stored on a wet floor. Leaks were observed from processing joints and water supply lines. * **Filling/Packaging