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 at 1830 2nd Ave N, Lake Worth, FL 33461-4202, following an inspection from February 6-14, 2006. The inspection revealed 19 observations related to food and drug manufacturing practices.

Key observations for food products included inadequate training of food handlers and supervisors, failure to protect food from contamination during mechanical manufacturing steps (e.g., inconsistent filling, uncapped bottles, missing tamper-evident bands, uncalibrated pasteurizer), and lack of proper maintenance for production equipment. Contamination risks were noted from employees emptying solutions onto the floor near production lines, improper storage of labels, and leaks in the mixing room. Issues with filling, assembling, and packaging included overflowing filler heads and hoses lying on the floor. Handwashing facilities were deemed insufficient, and a fan was observed blowing directly onto open bottles. Raw materials were not adequately inspected, with an expired raw material found. Extraneous material risks were present from ceiling particles, condensation drips, a glove stuck in a filling hose, and tape residue on equipment. Finished food storage conditions were inadequate, with warehouse temperatures exceeding recommended storage conditions for stability studies. Grounds maintenance was poor, with litter and waste attracting pests, and an open, unscreened vent allowed pest entry. Toilet