Overall, global CDER warning letter issuance has skyrocketed. Here we review the trends over the last five years in regard to facility type.
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.
Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing.
Here we look at the interval between inspection and issuance of warning letters and the interval between inspection and issuance of import alerts for FY2018 drug GMP warning letters.
There were a handful of warning letters issued to drug manufacturers. FDA continues an unrelenting focus on OTC and contract manufacturers.
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.