FDA 483 - perrigo florida inc - January 27, 2009

On January 27, 2009, the FDA issued an amended Form 483 to Perrigo Florida Inc dba Unico, a medical food, OTC drug, and cosmetic manufacturer located at 2201 4th Ave N, Lake Worth, FL. The inspection, conducted from January 14-27, 2009, identified five observations.

Observation 1 noted the failure to submit an adverse event report for a nonprescription drug within 15 business days of receipt. Specifically, Complaint #071808-1, received on July 18, 2008, for a serious and unexpected event related to Longs Wellness Preparation Cleansing Kit, Flavored Oral Saline Laxative, Lot #PK70010, was not reported to the Secretary of HHS.

Observations 2, 3, and 4 pertained to food manufacturing practices. Observation 2 cited the failure to manufacture foods under conditions that minimize microbial growth, specifically, not inverting bottles of Pediatric Oral Electrolyte Solution after filling and capping on all production lines. Observation 3 detailed failures in protecting food from contamination during filling and packaging, including loading plastic containers onto an uncovered hopper in an open warehouse area and wiping bottle caps with cloth rags immediately after filling. Observation 4 highlighted the failure to adequately clean equipment, specifically not disassembling filler nozzles for Pediatric Oral Electrolyte Solution for cleaning, sanitizing