FDA Finds Serious violations at Puerto Rico prescription manufacturing plant

Mylan is the world’s third-largest generic drug manufacturer and the FDA recently warned the company that they could face serious civil and criminal penalties and charges for inspection violations found in their Puerto Rico manufacturing plant.

According to a report, the FDA conducted inspections at Mylan’s Caguas, Puerto Rico plant and sent a letter warning the company to change how they made the drugs within 15 days.

Medicine quality and strength questioned at production plant.
Most of the violations pertained to the quality and strength of the medicines being sent out and shipped. Tests confirmed that drug quality was very poor in the Puerto Rico plant. The drugs manufactured there were mostly not strong enough, containing more fillers and binders than actual active medicinal ingredients.

Mylan Inc. is a global generic and specialty pharmaceuticals company headquartered in Pennsylvania, and it manufactures more than 45 billion doses globally.

FDA inspection rates not enough to regulate number of plants
The FDA is required by law to send inspectors to all U.S. drug manufacturing plants every two years. However, the FDA’s resources simply cannot keep up with the demand of inspection. While the FDA is required to prevent unsafe drugs from being put on the market, consumers cannot rely solely on state or federal regulatory agencies to protect them.

FDA does not have manpower to inspect global plants.
Drugs manufactured in China are often manufactured in substandard conditions, because they can get away with more lax standards, since the FDA says it does not have the manpower to inspect those plants, and inspectors from the companies that own the plants are often stonewalled by the Chinese government about getting in to inspect them.

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