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.)
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 months shorter than in FY2016. The high point for this interval was reached in 2016.
Conclusion
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: No need to click back and forth between blog posts—download the full report instead.)