Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month!
by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief
The EMA published their Annual Report for 2016 in May 2017, and it provides highlights of their work in partnership with the national health authorities. Christa Wirthumer-Hoche, chair of the EMA Management Board, provides the Forward to the report, and Guido Rasi, the EMA Executive Director, provides the Introduction. The report identifies important activities in 2016 and how they advance public health. It also holds a collection of graphics from a variety of areas including human and veterinary medicines, the European regulatory network, and inspections/compliance. The report also identifies 22 Annexes that may be found on the Agency’s website but are not included in the report.
Just a quick update – the FDAzilla Enforcement Analytics database was updated with data through April 25, 2017. We typically refresh the inspections data every 3 weeks or so, pair new warning letters with inspections every week, and add new 483s, EIRs, and 483 response letters every month.
As of now, our database has:
- 703,956 FDA inspections
- 194,757 manufacturing sites
- 5,668 FDA investigators
- 10,872 Inspection Documents
And the best part is that it’s all linked together.
The FDA has been writing up companies on data integrity since the year 2000. Even after all the horror stories, and even after billions of dollars of market cap have been erased from it, here we are in 2017, still talking about it.
Here is some troubling text from recent Warning Letters that cite data integrity:
“…our investigator observed your warehouse supervisor tearing out pages from your firm’s annual report and placing the pages into his pocket.”