A blog entry that evaluated FDA enforcement actions in the first half of FY2016 provided data to demonstrate that the interval between GMP drug inspections and warning letters almost doubled since FY2013. The relevant table and graph is provided below.
We’ve been watching this trend for the past couple of years, and now we are seeing the reverse—the interval has been steadily decreasing.
The interval peaked in late 2016 and then began to drop. For the last 14 warning letters in FY2016, by date of issue, the interval overall was 7.6 months, similar to the intervals for FY2013 and 2014. This includes warning letters to both compounding pharmacies and warning letters issued to firms outside the US.
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And the trend continued through FY2017. The average interval overall was 10.1 months, almost on par with FY2015 and decreased to 1.8 months from FY2016. The figures below show the breakout year by year since FY2013.
Figure 1: Interval Between Inspection and Warning Letters
There may, however, be a price to pay for those who use warning letters as learning tools.
In at least two of these 14 recent warning letters, the FDA appears to be limiting the statement of deficiencies to simply specifying the text of the regulation and its reference within 21 CFR 211. This is in contrast to what has been the more common practice of providing detail regarding the conditions that the FDA identified as not complying with the GMP regulations.
In others, details are provided but they seem to be less granular than previous warning letters. This seems to reflect the approach the FDA uses in warning letters to compounding pharmacies and outsourcing facilities that generally focus on the citing of the regulations alone and without additional detail.
The FDA has stated that they want pharmaceutical firms to learn from the deficiencies identified in warning letters and undertake their own remediation where necessary. Citing only the text of the regulation limits the learning that can be gleaned from warning letters. The text of the examples resides in the form 483 associated with the warning letter. We would ask the FDA not to diminish the extent of this information based on its benefit to the industry.
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 Effective for drug warning letters published on the FDA website on October 11, 2016.
About the Author
Barbara W. Unger formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.
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