Pest Problem Prompts 483 at Puerto Rican Facility

July 1, 2016

A Puerto Rican drugmaker’s pest problem resulted in a two-observation Form 483 over sanitary conditions.

FDA inspectors reported finding dead insects on top of bins used to transport ingredients to the blending room to manufacture simvastatin tablets. Additionally, the blending room had not been cleaned for nearly two weeks, raising concerns about the sterility of that batch.

Inspectors also noted pests on the facility’s deck, taking residence in unused equipment such as vehicles. One inspector examining a trailer parked on the deck found it contained a dog and beehive.

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