The Ultimate Guide to FDA Product Recalls - MasterControl

Why FDA Product Recalls Happen and How to Avoid Them

When the U.S. Food and Drug Administration (FDA) initiates the recall of a product, it’s costly for life sciences companies, causing significant financial losses, reputation damage, and even legal repercussions. In the past several years, FDA recalls have been on the rise, especially in the pharmaceutical and medical device industries. Because of the tremendous impact their products have on public health and consumer perception, it’s essential for these companies to prevent these recalls from happening. This guide provides life sciences professionals with a deeper understanding of the causes of FDA recalls, their aftermath, and why MasterControl solutions are the best option to help companies avoid them.

Lives of Life Sciences: Inspection Observations

For product safety and compliance to be upheld, life sciences companies are required to adhere to the highest standards of product quality. They are subject to rigorous FDA risk inspections to ensure that regulatory guidelines are followed throughout the life cycles of their products. It’s the reality of doing business in a highly regulated field. FDA investigators evaluate manufacturers’ processes, documentation, facilities, operations, packaging/labeling, and more to ensure they are compliant with regulatory requirements. During these investigations, the auditors will make note of any issues they deem to be noncompliant with FDA regulations. If the inspectors observe such issues across any aspect of their operations, the manufacturers are cited.

What Is an FDA Form 483?

At the conclusion of an inspection, observations are issued in an FDA Form 483 to firm management when the investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when, in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device, or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health. In 2023, the FDA issued 4,428 Form 483s, with 1,230 of those going to life sciences companies. The top 5 industries cited with Form 483s were:

Top 5 Reasons for FDA Citations

When FDA investigators take note of issues that could compromise the quality of life science companies’ products and, thereby, public safety, they typically fall into the same group of common shortcomings:

1. Inadequate quality event management procedures in place
2. Absence of written procedures or documentation
3. Lack of investigation into batch failures
4. Inadequate process validation
5. Inadequate training procedures

SeerPharma's business partner MasterControl* explores these common categories further in publication The Ultimate Guide to FDA Product Recalls - Why They Happen and How to Avoid Them. You can access the full 14-page document simply by submitting the webform below to also read more about:

• Potential Result of FDA Observations: Product Recalls
  • By the Numbers: Increase in Recalls and Effects on Consumer Safety
  • Impact on Bottom Lines
• Upstream Impact: Erosion of Consumer Trust
  • Survey Insights: Public Perception of Recalls and Trust Issues
  • Long-Term Consequences of Product Recalls
  • How Recalls Affect Consumer Behavior and Brand Loyalty
• Avoid Recalls by Having the Right Solutions in Place
  • The Ideal Solution for Recall Prevention; addressing the 5 common categories of FDA observations listed above.

*About MasterControl

MasterControl Inc. is a leading provider of cloud-based quality and manufacturing software for life  sciences and other regulated industries. For three decades, our mission has been the same as that of  our customers – to bring life-changing products to more people sooner. MasterControl helps organizations digitize, automate, and connect quality and manufacturing processes. Innovative MasterControl tools have a proven track record of improving product quality, reducing cost, and accelerating time to market. Over 1,100 companies worldwide use MasterControl solutions to streamline operations, maintain compliance, easily analyze and interpret large amounts of data, and visualize business insights in real time.

Submit the form below to access the full MasterControl article The Ultimate Guide to FDA Product Recalls - Why They Happen and How to Avoid Them.