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FDA inspection reports consistently show that the corrective and preventive action process is the biggest inspection problem for medical device facilities. And those who have to implement CAPAs have plenty of questions about how best to manage them. Read More
The FDA issued a warning to Florida-based ProSun International over significant GMP and branding violations revealed during an August inspection. Read More
The FDA is now monitoring about 90 medical products, including devices, biologics, and drugs, that are manufactured in Puerto Rico and are critical to patient health. Read More