Part 2: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1


It all starts with Table 1…

  • Table 1 shows the fifteen (15) most frequent inspection observation citations (the tabulation on the FDA website shows all).
  • Table 1 presents data in the order of those observations with the highest to lowest number for 2017, modified as described in the ‘Introduction’ section of this series.
  • Both Table 1 and Figure 1 show consistency in the years between FY2013 and 2017 with respect to the overall identity of inspection observations.
  • Investigations, covered in 211.192, remain at the top of the list for all 5 years, albeit tied last year for that position.
  • In 5 instances, the number of times FDA cites a specific regulation changed markedly in FY2017, and I highlight these in gray in Table 1.
    • Table 2 shows only these 5 citation differences from FY2016 and FY2017.
  • Table 1 shows 3 regulations which decreased in the number of times FDA cited them in FY2017 compared to 2016:
    • 211.42(c) (facilities shall include defined areas of sufficient size)
    • 211.166(a) (stability testing)
    • 211.67(a) (equipment cleaning, sanitization, and sterilization)
    • These 3 regulations continued a downward trend that started in FY2015 as shown in Figure 2.
  • Table 1 show 2 regulations which saw significant increase in FY2017 over FY 2016 regarding the number of times FDA cited these inspection observations:
    • 211.188 (master production and control records)
    • 211.160(b) (lab controls with scientifically sound specifications)
    • For the 2 where the number increased, 1 more than doubled and the other increased by approximately 55% over FY2016.

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I cannot unambiguously point to the reason(s) for the differences. FDA has focused increasingly on OTC manufacturers, and many of their inspections have cited either lack of, or incomplete, batch records. Emphasis on laboratory controls and specifications may have increased for similar reasons. I’ve not seen hard data to suggest reasons for either those which have decreased in number or those which have increased.

TABLE 1: Inspection Observations Issued Using FDA Tools for the Fiscal Year 2017.  These are presented in the order of highest to lowest.

Figure 1

TABLE 2:  FDA Regulation Citations in FY2016 and FY 2017 Inspections for Selected Areas.

Click here for Part 3 and this series’ conclusions…

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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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