Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! Continue reading
We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to establish adequate written procedures to not submitting periodic adverse drug experience reports.
From pharmaceuticals in New Jersey, China, and more, here they are (starting with the most recent):
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.
We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from “products being misbranded” to sites “not ensuring that test procedures are scientifically sound.”
From pharmaceuticals in India, Pennsylvania, and more, here they are (starting with the most recent):
by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief
In 2015 we published a collection of FDA GMP warning letters that included deficiencies in data governance and data integrity. Here we provide the same information for 2016 drug GMP warning letters. These should serve as a resource for GMP audit staff and QA staff as they evaluate their own firms and contract sites for gaps in these areas. In this introduction, we provide tables and graphs identifying the dates of the warning letters, firms to which they were issued, and the country where the facility is located. We also provide a table that shows the trends over time for location of countries where facilities receiving these warning letters were located, beginning in 2008. And, finally, we provide a tabulation of the regulations most frequently cited for these deficiencies in 2015 and 2016.
We took a snapshot of the 8 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to monitor the water purification system to personnel not wearing appropriate clothing to prevent contamination.
From pharmaceuticals in California, Singapore, and more, here they are:
New data synthesized by FDAzilla has revealed several dramatic shifts with FDA inspection and enforcement activity.
The FDA issued 15 pharma GMP-related warning letters to manufacturing sites in China in 2016 – a 5-fold increase from years prior. China averaged 2.7 Warning Letters per year from 2013 to 2015. This explosion was led mostly by infamous FDA investigator, Peter Baker, who performed 17 inspections in China in 2016, leading to 13 FDA Form 483s and 4 Warning Letters. Continue reading