We cover one device warning letter and review a mislabeling of PURELL Hand Sanitizer.
We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area.
This week, one warning letter was issued to an HCT/P firm and three were issued to OTC manufacturers located outside the US.
FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape. While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.
FDA posted four GMP drug warning letters, all to firms outside the US. One of the letters reinforces the need to monitor import alerts to ensure that suppliers and CMOs are not on the list; the consequences of missing this can be serious as this firm learned.
The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices. This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process.
This week we cover three warning letters: two to pharma firms and one to a clinical investigator.