Did you know that “data integrity” is the second most-cited keyword in CDER warning letters? Or that it ranks 33rd of 483 cited keywords?
CDER inspections in the Asia Pacific region are up 103% since 2013. How has that influenced enforcement actions? And what about your supply chain?
Overall, global CDER warning letter issuance has skyrocketed. Here we review the trends over the last five years in regard to facility type.
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.
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 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.
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.
This week, one warning letter was issued by CDER to a finished pharmaceutical manufacturer, and another was issued to a Genetech site that manufactures human cells/tissue-based products.
FDA posted four warning letters this week including one to an API manufacturer, one to a compounding pharmacy and one to a drug product manufacturer.