This article, the first in a series, offers a detailed summary of the drug GMP warning letters issued in FY2018 as well as a comparison of trends since FY2013.
This week, enforcement was busy with a GLP warning letter, warning letters to an API manufacturer, a pharmaceutical firm, a couple of compounding pharmacies, and a device firm.
We cover four recent warning letters, including one to a drug manufacturer, one to a distributor, and two to medical device firms.
The global supply chain for drug products has become increasingly more complicated, and as such has expanded the scope of sites FDA must routinely inspect.
FDA issues the first warning letter citing failure to comply with requirements of the Drug Supply Chain Security Act (DSCSA) amendments to the FD&C Act.
This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert.
The global supply chain for drug products sold in the US has become increasingly more complicated in the past decades.
Now that the government shutdown is over, at least for 3 weeks, FDA has started publishing warning letters. We have two from this week.
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.