Review of Microbiological Involvement in Product Recalls

Webinar to be presented Thursday, February 9


CMGP lessons can be learned from many sources including 21 CFR (parts 111, 211, 612, etc) as well as guidance documents, USP informational chapters and industry technical reports. Another source of extremely useful information are Recall enforcement reports provided by FDA on their web site. This webinar looks back at a history of recall summaries over the years to determine causes of recalls from a variety of industries regulated by FDA.

A recent analysis was conducted of 642 microbiologically-related recalls over the years 2004-2011. The microbiologically-related recall activity shows a decided increase in recent years. Most of the reported recalls involved sterile products, and of these medical devices accounted for the majority. The reasons given for sterile product recalls were varied, but the majority cited “Lack of Sterility Assurance” with sterile packaging clearly identified as the main culprit.

There was significant information in the recall data for non-sterile products as well. The majority of the recalls came from OTC and personal care products, with “Objectionable Organisms” as the most prevalent reason for recall by a wide margin. These recalls are further analysed to provide indication of the FDA policy on what is an objectionable organism, along with a review of current regulatory guidance. Finally, recommendations are presented in determining an “Absence of Objectionable Organism” policy for a manufacturer.

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Scott Sutton, Ph. D.

Dr. Scott Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Microbiology Network, Inc. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. He operates the Pharmaceutical Microbiology Forum with its monthly newsletter ( and serves as a reviewer for several peer-reviewed journals. Dr. Sutton also operates an information source on the internet – The Microbiology Network ( that provides services to microbiology related user’s groups. This service also supports three Email lists, the first devoted to pharmaceutical microbiology, the second devoted to pharmaceutical stability and the third to cleanrooms and controlled environments.

Key Topics

  • Enforcement Report Information Available
  • Overview of Recalls by Product Category
  • Sterile Product Recalls
    • Finished Product Issues
    • Lack of Sterility Assurance
      • Packaging
      • GMP / other manufacturing issues
  • Non-sterile Product Recalls
    • Microbial Contamination
    • Objectionable Organisms
  • Conclusions