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):
by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief
The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013. This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products. Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.
by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief
We’ve all been following the health authority’s identified deficiencies in data governance and data integrity for the last few years, though this enforcement action has been ongoing for almost twenty years. A comprehensive GMP Intelligence program follows 483s and warning letters for information on the FDA’s focus. Particularly in this area, the best learning materials are often provided by the regulatory authorities like the FDA. The early deficiencies in this area cited disagreement between data submitted to the FDA in a regulatory filing vs the original data identified at the site. Most recently the use of ‘integration interruption’ capability of chromatography data systems has been identified as a means of data manipulation. In addition, some firms have gone to extremes in physically blocking the FDA’s access to areas which they have a right to inspect.
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):
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.”