483s and warning letters are increasing in both volume and speed, with the FDA issuing 98 letters in FY2019 compared to just 19 four years earlier. The letters are also coming closer to the end of inspection at a rate of just 6.5 days.

In other words, the 483s and warning letters will not be relenting.

The categories of Devices and Drugs received the second- and third-most 483s, behind only Food. What’s the major cause? While “lack of or inadequate procedures” is the most frequently cited issue in the Devices and Drugs categories, issues related to data integrity were responsible for a significant portion of 483s in 2019.

Companies that can identify, remediate, and prevent data integrity issues will have a distinct advantage over those that continue to let data and procedures go unchecked.

5 Ways to Address Data Integrity and Process Issues to Minimize 483s and Warning Letters

In our in-depth white paper, we explore five strategies that pharmaceutical, medical device, and biologics manufacturers can employ to reduce the risk of 483s and warning letters related to data integrity. Our suggestions include:

  1. Get strict about maintaining device history records
  2. Establish clear, specific document control procedures across the board
  3. Establish a reliable vendor audit program
  4. Invest in electronic batch records software for faster, more accurate recordkeeping
  5. Combat concurrent documentation issues

In addition to our tips and insights, we identify the most common 483s related to each suggested area of improvement.

Download the white paper to get a better understanding of the current state of 483s and a roadmap for preventing data integrity issues through sound commissioning, qualification, and validation  practices.