Part 3: An Analysis of FDA FY2018 Drug GMP Warning Letters

This series focuses on FDA enforcement surrounding drug GMP warning letters issued in FY2018. In parts one and two, we covered:

  • Drug GMP warning letter trends since FY2013.
  • Warning letters outside the U.S.
  • Enforcement of over-the-counter (OTC) and contract manufacturers/laboratories.
  • Import alerts associated with warning letters.
  • Data integrity deficiencies.

Here we look at the interval between inspection and issuance of warning letters and the interval between inspection and issuance of import alerts.  We also compare this data from 2018 to that of the previous five years.

The data presented here for FY2018, ending Sept. 31, 2018, is based on drug GMP warning letters posted by the FDA no later than Jan. 1, 2019.

Following are brief highlights of noteworthy findings, followed by a more detailed analysis:

  • The interval between inspection and issuance of warning letters continues to decrease for all categories, though the most dramatic decrease has been for warning letters issued to sites outside the U.S.
  • Warning letters issued to compounding pharmacies and outsourcing facilities continue to take the longest time to issue after inspections are completed.
  • The interval between inspection and issuance of import alerts continues to be just under 50% of the time between inspection and warning letter issuance.

(NOTE: No need to click back and forth between blog posts—download the full report instead.)

LI Special Report - WL


Intervals Between Inspection and Warning Letter

Figures 1 and 2 show the interval between inspection and issuance of a warning letter for the six most recent fiscal years.  The data for all three major categories shows a decrease in the time between inspections and warning letter issuance.

The most significant change happened for the sites outside the U.S., which saw a decrease from 10.4 months in FY2016 to 8.0 months in FY2017.  The time between inspection and warning letter issuance is longest for compounding pharmacies at 12.6 months, though this is about 0.5 month shorter than in FY2016.  The high point for this interval was reached in 2016.



Figures 3 and 4 show that the interval between the inspection and imposition of an import alert decreased in FY2018 compared with FY2017.  These data include only those associated with warning letters and may not be representative of import alert timing for firms who do not receive a warning letter.

Though only three years are represented here, the time interval has consistently decreased. The import alerts addressed here include failure to follow GMPs (Import Alert 66-40) and refusal of inspection by a foreign establishment (Import Alert 99-32).





Among compounding pharmacies, manufacturing firms within the U.S., and manufacturing firms outside the U.S., there has been a consistent decrease in the amount of time between inspection end date and issuance of drug GMP warning letters over the last three years.

The issuance of import alerts continues to occur within roughly half the amount of time of a warning letter over the last three years.  The interval between inspection and import alert has decreased at an average of just under one month year over year, whereas the interval between inspection and warning letter has decreased at an average of just under two months.

(NOTE: This report by GMP expert Barbara Unger has been adapted into three blog posts.  If you would like a copy of the full report, you can download it here.)

LI Special Report - WL


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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She 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.

Unger Consulting Inc. | | 805.217.9360

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