perrigo florida inc – FDA 483, Jul 13, 2006

This FDA Form 483 document details observations from an inspection of a facility producing pasteurized pediatric electrolyte oral solution.

On July 10, 2006, during the manual capping of plastic bottles for Lot #UN62117, workers failed to wash or sanitize their hands or gloves before or during the process. They repeatedly touched conveyor equipment and a trash barrel without sanitizing, potentially contaminating the food product.

Additionally, on July 10, 2006, the fill room supervisor directed workers to manually cap bottles of pediatric electrolyte oral solution (Lot #UN62117) when the automatic capping machine malfunctioned. This action, instead of stopping the line for repairs, exposed the product to post-pasteurization contamination. This indicates a lack of assigned competent supervisory personnel responsible for ensuring compliance with current good manufacturing practices related to personnel.

Furthermore, on July 11, 2006, the laboratory technician conducting pH measurements for Lot #CO62129, pediatric electrolyte solution, could not verify the use of unexpired pH 4 and pH 7 buffers to standardize the pH meter. This suggests inadequate maintenance of instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms.