Interval Between Inspection and Warning Letters Starts to Decrease

Interval Between Inspection and Warning Letters Starts to Decrease

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief


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.

Recently, this interval shows signs of decreasing.  For the last 14 warning letters in FY2016[1], by date of issue, the interval overall is 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.  An upcoming evaluation of drug GMP warning letters for FY2016 will include data as collected for all of FY2016.  Look for the full year worth of data to be published here in mid-November, 2016.  The FDA fiscal year ended September 31, 2016.  We will also monitor and report whether this trend continues into FY2017.

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[2], 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 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.  

Table 1.  Interval Between Inspection and Warning Letter in Months

  FY2013 FY 2014 FY2015 1H FY 2016
TOTAL WLs 6.7 8.8 10.3 12.4
Compounding Pharmacies 3.7 10.5 10.8 12.5
US sites (non-compounders) 8.3 7.1 4.5 12.6
OUS 6.4 6.5 10.6 12.3

Figure 1:  Interval Between Inspection and Warning Letters



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[1] Effective for drug warning letters published on the FDA website on October 11, 2016.

[2] Note the following warning letters:  Laboratoire Sintyl S.A., Mappel Industria de Embalagnes, SA,


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