We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
No documentation was found indicating that the firm followed up to obtain missing or additional information or issued a device recall that would have aided in the investigation. Read More
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