“It’s a full thickness tear of your right rotator cuff.”
Not words I ever wanted to hear, let alone leading up to a holiday. But this diagnosis gave me the opportunity to consider the safety and efficacy of the medical devices and drugs involved in its treatment on a personal level, from the standpoint of the end user.
My pre-Christmas surgery comprised arthroscopic repair to shave the bone and enable greater range of motion for the rotator cuff, a fixation device and suturing to repair the torn tendon, and drugs to anesthetize, manage pain, and ward off infection. It was followed by six weeks with my right arm in a sling, and 12 weeks of physical therapy.
For those of us working in the Life Sciences industry, it’s common to view our own medical conditions, or those of family members, through the lens of our work. And that’s exactly what I found myself doing during those months of treatment, recovery, and rehabilitation. “What company made this fixation device?” I found myself wondering. “Do they have any citations from the FDA?” “What about the company that made the pain medication I’m using?”
Learning From Compliance Issues
My questions originally focused on wanting to discover if any of the manufacturers of products used in and after my surgery had ever been inspected by the FDA or issued a warning letter for non-compliance. However, upon visiting fda.gov/ICECI/Inspections/ucm589892.htm, I began to consider the broader, industry-wide implications of citations and warning letters.
Every year, the FDA publishes a report detailing the number of warning letters (FDA 483s) issued, along with a breakdown of what specific non-compliance issues were cited in those 483s. For fiscal year 2017, just over 5,000 483s were issued across nine product areas: Biologics, Bioresearch Monitoring, Devices, Drugs, Foods, Human Tissue for Transplantation, Parts 1240 (Control of Communicable Diseases) and 1250 (Interstate Conveyance Sanitation), Radiological Health, and Veterinary Medicine.
As companies seek to hone their strategic planning for 2018, they can gain valuable insight from the most common non-compliance issues cited in 483s for their product area, choosing to refine objectives and focus their compliance efforts on those higher risk issues.
Non-compliance Issues in Biologics
The top three non-compliance issues in the product area of Biologics make up 77% of the 115 483s issued in FY 2017. In fact, a full 42% of all non-compliance issues for Biologics fall into one category: Establishing, maintaining, and following SOPs.
The FDA cites establishing and following written standard operating procedures, particularly with regard to adhering to all of the required steps for collection, processing, storage, and transportation of blood and blood products, as the number one area companies dealing with Biologics fall short.
Following up with roughly 17% each of all issued 483s in Biologics are thorough investigations and required records. In FY 2017, the FDA issued 20 483s for failure to thoroughly investigate and document discrepancies, and the same number for failure to maintain proper records for donors, processing, storage, quality assurance, etc.
Noncompliance Issues in Medical Devices
With 1,030 483s, the product area of Devices was second only to foods in number of FDA citations issued in FY 2017.
By far the largest area of non-compliance was lack of procedures or inadequate procedures. Almost 40% of all 483s in Devices noted that procedures for corrective or preventive action were not sufficiently established by the cited companies.
Coming in at 26%, the second most cited issue is a related one: lack of or inadequate complaint procedures. The FDA issued 269 483s to Device companies for failure to sufficiently establish procedures for intake and evaluation of complaints by a designated department or unit.
Lack of or inadequate procedures, this time with regard to purchasing controls, rounds out the top three. Thirteen percent of 483s in this product area revolve around insufficient procedures to ensure that purchased products and services conform to specified requirements.
Non-compliance Issues in Drugs
Over a quarter of the 694 483s issued in Drugs were due to procedures either not being written out or not being fully followed. The FDA issued 185 citations for failure to maintain and fully follow written procedures related to quality control.
Establishment and maintenance of appropriate controls continues to be an issue with the second highest percentage of 483s: Roughly 18% of all 483s issued in FY 2017 in Drugs were due to shortcomings in scientifically sound laboratory controls. The FDA notes that companies cited for this issue had laboratory controls which failed to establish standards and procedures to ensure containers, materials, and products conformed to appropriate quality and purity standards.
Failure to investigate discrepancies, or the failure of any batch of medication or its components to meet specifications, made up 15% of last year’s 483s in Drugs. Significantly, this non-compliance issue was cited for batches whether or not they had already been distributed.
In reviewing the 483s issued by the FDA in FY 2017 in the three major product areas of Biologics, Devices, and Drugs, a theme emerges—and an opportunity. Establishment and following of procedures as relates to quality, investigation of discrepancies, and accuracy of record keeping come to the forefront as issues that call for improved diligence. As professionals committed to the health of our companies and the Life Sciences industry, we can turn to this valuable data each year and use it to inform our own decisions about how to minimize risk of citation and set goals and objectives for optimal performance and profitability.