We cover warning letters outside the U.S., enforcement of OTC and contract manufacturers/laboratories, import alerts associated with warning letters and data integrity deficiencies.
This week we cover four warning letters: one to a device firm, two to drug manufacturers, and one to a cosmetics company. The two drug warning letters were issued to firms that manufacture OTC products, continuing FDA’s focus on this market segment.
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.
After fifteen years of zero FDA enforcement activity, Immunomedics was hit hard not once, but twice in one month. The second punch was concerning enough to thrust them into the spotlight, causing their stock to be sold and their shares to plummet.
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.