FDA Warning Letter & Enforcement Trends of 2017: A Year in Review

As we enter the new year, it’s important to pause and look back the major trends in FDA enforcement that offer a valuable glimpse into what has changed from previous years and what we can likely expect in 2018.

We’ve focused on reviewing three areas of the FDA-regulated environment in particular: drugs, devices, and biologics.

There was an overall increase in the number of drug GMP warning letters from the previous year.

• 42 in FY2015

• 102 in FY2016

114 in FY2017

The number of warning letters to drug product manufacturing sites doubled from the previous year.

• 9 in FY2015

• 23 in FY2016

46 in FY2017


Compounding pharmacies and outsourcing facilities continued to see disproportionately heavy enforcement action from FDA compared to FY2013, FY2014, and FY2015.

• 3 warning letters in FY2013

• 27 warning letters in FY2014

• 24 warning letters in FY2015

• 56 warning letters in FY2016

45 warning letters in FY2017


Excluding compounding pharmacies and outsourcing facilities, two and a half times as many warning letters were issued to firms outside the U.S. compared to domestic organizations.

The amount of time between inspections and the issuance of a warning letter decreased across all FDA-regulated industries, especially for warning letters issued to foreign sites.

• 11.9 months in FY2016 for all warning letters

• 10.1 months in FY2017 for all warning letters


Data integrity issues were cited in 65% of all warning letters, including those issued to compounding pharmacies.


Procedures for corrective and preventive action (CAPA) remained the most-often cited compliance issue for medical device companies.

• The lack of or inadequate procedures established for CAPA was cited 400 times in Inspectional Observations issued to the medical device industry in FY2017.

Compliance issues related to establishing, maintaining, and following manufacturing SOPs was the most frequently cited to biologics.

• Poor SOPs were cited 49 times in FY2017.

 

Our Most Popular Content of 2017

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Webinars:

 

Preparing for the Medical Device Single Audit Program

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Harmonizing Disparate Quality Systems

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The Importance of CGMP to the Safety of Compounded Drugs

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Blog Posts:

The Differences Between GCP, GLP and GMP Audits 

 

The Biologics License Application (BLA) Process Explained 

 

A Basic Guide to Mock FDA Audits  

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