BASIC GMP, GMP Enforcement, Quality / CMC Guidance, and More…
We cover four warning letters from last week including two to pharmaceutical firms and two to compounding facilities. The FDA has not yet published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a couple weeks ago.
We cover four warning letters this week including one for a human drug and three to device manufacturers, two of which are manufacturers of breast implants that failed to conduct post-approval studies.
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.