Poor Training Procedures Result in a 483 for Perrigo

The FDA found Perrigo’s training system for detecting foreign matter to be severely lacking, resulting in a Form 483 for the drugmaker.

During a September inspection of Perrigo’s Holland, Mich., facility, investigators were troubled that there was no documentation that analysts inspecting raw materials, tablet mixes and granulations for foreign particles were in fact capable of performing that action.

Analysts are trained on a lot consisting of 100g of a sample material with foreign matter seeded in the sample, reads the form with three observations. “There is no procedure describing how to create the training lot (i.e. materials chosen based on type and color, foreign matter materials and size),” said the FDA.

One employee was trained using this method in 2013. That same employee evaluated a lot of naproxen sodium gran and recorded a passing result for significant foreign matter particles.

The lots were later used in a final drug product of naproxen NA released back in May 2014, the agency said.

Perrigo did not return a request for comment as of press time.

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