FDA 483 - perrigo florida inc - July 19, 2007

This FDA Form 483 details observations from an inspection, citing multiple failures in contamination control and facility maintenance for pediatric OES (Oral Electrolyte Solution) products.

**Violations and Observations:**

* **Contamination Control Failure:** The firm failed to prevent microbial contamination. * Lots GR70774 and GR70825, manufactured on 2/26/07, failed in-house microbiological testing on 3/2/07 but were subsequently distributed to customers in the US and Canada, despite a Quality Control Hold Form identifying the failure and reporting product destruction on 3/14/07. * A customer complaint (102006-01, 10-20-06) reported microbial contamination in pediatric OES Lot GR62459, leading to the destruction of 60,048.7 oz. by the customer. The firm did not expand the investigation or disposition for the remaining 17,982 oz. of the same lot distributed to other US customers.

* **Equipment Maintenance and Sanitation:** Equipment, containers, and utensils were not maintained to protect against contamination. * The mechanical bottle capping equipment was severely corroded and tarnished with dust and dirt accumulation, exposing OES-filled bottles. * An overhead plexiglass covering on the conveying line adjacent to the