Different Year, Same Results: QA the No. 1 FDA Drug GMP Inspection Lapse for FY2019


In the 1993 comedy film “Groundhog Day,” a TV weatherman played by Bill Murray is disturbed to learn that every day his alarm clock goes off and he awakes, he’s stuck in a time warp reliving the same day over and over again with no end in sight. He begins to think he’s going mad until he discovers a way to play the phenomenon to his advantage.

On Sept. 30, 2019, the U.S. Food and Drug Administration (FDA) released its top GMP inspection findings for FY2019 and — surprise, surprise, you guessed it — the No. 1 most common FDA Form 483 issued to pharmaceutical manufacturers was a failure to document quality unit responsibilities and procedures, or in FDA parlance, “responsibilities and procedures for the QA unit are not in writing or fully followed [21 CFR 211.22(d).”(1)

A deeper dive into this issue analyzes this trend, why it’s reoccurring and what actions pharmaceutical companies can proactively take to avoid falling into this familiar pattern.

The Latest Metrics

In FY2019, the FDA reported 185 instances of violations for failure to properly document quality responsibilities as required (Figure 1) by 21 CFR 211.100(a). That is 50 times more than the second most common violation, a failure to thoroughly review unexplained discrepancies or batch/component failures to meet specifications, according to FDAnews. An article on Bioprocess Online indicated that the total numbers of FDA GMP drug warning letters are also trending upward.(2) The total FDA GMP drug warning letters increased from 42 in FY2015 to 102 in FY2016 and then to 114 in FY2017 and topped out at 127 in FY2018. Another alarming metric is that data integrity deficiencies were cited in 57 percent of all warning letters in FY2018, according to the Bioprocess Online report.


Figure 1: Drug GMP warning letters issues by the FDA, Bioprocess Online, 2019

An accurate documentation of a pharmaceutical manufacturers’ SOPs is required to comply with FDA current good manufacturing practices (CGMP) in order to help ensure the safety, efficacy and purity of the drugs they produce. Any deviation from maintaining the highest level of quality processes in manufacturing leaves manufacturers open to greater regulatory scrutiny and actions. CGMP requirements for drugs include minimum standards for the methods, facilities and controls used in the manufacturing, processing and packaging of a drug.

Didn’t We Already Have This Conversation?

But again, what’s troubling about this year’s GMP inspection citation data is that it seems all too familiar. And it doesn’t just seem like a letdown of companies’ quality teams to provide proper documentation; the facts back it up.  

Dell Moller, an FDA supervisory consumer safety officer, in a presentation at the FDA/Xavier PharmaLink Conference at Xavier University in March 2019 shared a graphic (Figure 2) that not only has the agency’s No. 1 GMP inspection violation been trending for several years, but it was also the most common violation FY2014-FY2019 and also FY2006.(3)


Figure 2: FDA observations for the last five fiscal years and FY2006 for comparison. The citations are color-coded with the blue color representing the most common category of citation, the failure to document quality unit responsibilities and procedures.(3) Pharmaceutical Online, 2019.

“[FDA news analysis of the inspection reports] show that drugmakers continue to stumble at the same old hurdles. … [Improper documentation of quality] has been the top citation for over a decade — often by a wide margin,” the news bulletin states.(1)

With no change in the trend in sight, manufacturers need to look to new ideas and solutions to ensure that the quality assurance documentation required by inspectors is accurate and complete.

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Stopping the Cycle

At the same conference, Moller outlined some specific things that pharma leadership, managers and quality professionals can ask themselves to help create a more vertical companywide culture of quality within their organizations with an emphasis on averting the GMP inspection citation trend and improving quality documentation.(3)

  • Is there a quality mindset (from top to bottom) in all aspects of the operations, not just the quality unit? Is the CEO (or owner if it’s a smaller company) buying into the same thing management and shop floor personnel are buying into?
  • Is the manufacturer doing the right thing because it is the right thing to do, not just because the FDA expects it, and not just in the documentation, but in all operations?
  • Does the inspection indicate that quality permeates throughout the company environment? Is it systemic?
  • Ensuring quality doesn’t just mean putting up metric posters or having the slogan “Right First Time” or “There is no ‘I’ in Team.”

Technology is another avenue available to manufacturers looking for ways to tighten up quality and document control efforts in order to foster greater cooperation and reduced friction between the quality team and shop floor employees. From blockchain and predictive analytics to artificial intelligence and big data strategies, digital solutions are much welcomed in an industry overflowing with data and in which manufacturers are struggling to accumulate, organize and make sense of that data.

To gain greater improvements in the quality of their data, life sciences manufacturers are increasingly replacing manual, paper-based systems, which are more prone to bad data entry, and turning to electronic quality management systems (QMS). An automated QMS allows a manufacturer to digitize and accelerate quality while tracking production in real time so that mistakes are caught and remedied through corrective and preventative action (CAPA) — and putting the ‘p’ in CAPA — before finished product is ready to ship.

Similarly, a digital production records solution can be a game-changer for a pharmaceutical company as it ensures that the data contained in batch records is accurate and free of the bad data as they move along the shop floor. During production, bad or inaccurate data is often manually entered by shop floor users, a common problem that can add hours if not days to the review process for each batch. A digital production records solution speeds up the entire production process, saving manufacturers valuable time and helping eliminate shop floor delays while freeing up shop staff for more meaningful and productive tasks.


George Santayana, a Spanish-American philosopher, coined the well-worn expression “those who cannot remember the past are condemned to repeat it.” Accordingly, pharmaceutical manufacturers have at their disposal the insights and resources that can help them disrupt the seemingly endless conveyor belt of data entry and documentation errors the lead to FDA GMP inspection gaffes. Incremental digital upgrades can provide significant improvements and help put manufacturers’ inspection regimen and quality program on a more-sure footing. Rather than living in the past, pharma organizations can incorporate and implement the latest technological tools that will take their quality assurance, compliance and manufacturing standards to the next level.


  1. “FDA’s Top GMP Inspection Findings for FY2019” FDA News. Sept. 30, 2019. https://www.fdanews.com/articles/192882-fdas-top-gmp-inspection-findings-for-fy-2019
  2. “An Analysis of FDA FY2018 Drug GMP Warning Letters” by Barbara Unger. Bioprocess Online. Feb. 1, 2019. https://www.bioprocessonline.com/doc/an-analysis-of-fda-fy-drug-gmp-warning-letters-0003
  3. “FDA’s Top 5 Drug GMP Inspection Citations in FY2018 — With FDA Analysis” by Jerry Chapman. Pharmaceutical Online. Sept. 16, 2019. https://www.pharmaceuticalonline.com/doc/fda-s-top-drug-gmp-inspection-citations-in-fy-with-fda-analysis-0001

Rigert_Mike_HS11088Mike Rigert is a content marketing specialist at MasterControl's headquarters in Salt Lake City, Utah. He has nearly a decade and a half of experience creating marketing and journalism content for the tech industry, news media, and higher education. Rigert has written a wide gamut of content types from feature magazine articles to industry white papers and technical product documents to press releases and blog posts. At MasterControl, a portion of his duties include serving as editor of the organization’s prospect blog, GxP Lifeline. Rigert holds a bachelor’s degree in political science with an emphasis in international relations from Brigham Young University.