2015 FDA Form 483 Observations

There are few things more stressful than having an FDA Inspection. Unfortunately, receiving an FDA Form 483 is one of them. FDA Form 483 observations are a matter of public record. Potential consumers and investors can access this data, and Form 483 observations are reviewed for FDA warning letters.

Thankfully, a well designed and maintained Quality Management System can save your company from a 483 and we are here to help. The FDA has posted medical device 483 observation statistics for 2015 and we have tallied up the top 5 most common observations to highlight a few areas your company may want to focus on this year.

483 Observations ChartNo. 5 – MDR procedures

In fifth place, with 129 observations, is a lack of or inadequate written MDR procedures. That is 13% of medical device Form 483s in 2015 containing an MDR procedure issue. MDR procedures have made the top 5 list of most common observations for the last 10 years, peaking at the second most common observation (15%) in 2010 before falling back down to third or fifth place in the last 5 years.

But don’t let its rank fool you. MDR procedure observations have been on the rise again, increasing from 11% to 13% of observations over the last 3 years. With the implementation of eMDRs becoming final in August 2015, MDR observations may be an even larger issue in 2016.

No. 4 – Inadequate Process Validation

In fourth place, with 134 observations, is a lack of or inadequate process validation. That is 13% of medical device Form 483s. Process validation observations have ranked fourth for the last 3 years and have made the top 5 list in 8 of the last 10 years.

No. 3 – Inadequate Purchasing Control Procedures

In third place, with 139 observations, is a lack of or inadequate purchasing control procedures. That is 14% of the medical device Form 483s in 2015. Purchasing procedures is a relative newcomer to the top 5 list. It debuted in fourth place in 2012 and has been holding third place ever since. The FDA suggests the increase in purchasing control issues is likely due to device makers relying solely on a purchase order instead of procuring a quality agreement.

No. 2 – Inadequate Complaint Procedures

In second place, with 294 observations, is a lack of or inadequate complaint procedures. That is 29% of the medical device Form 483s and more than twice as many observations as purchasing controls. Complaint procedure observations have been gradually increasing over the last 10 years and have been the second most common observation for the past 5 years. The FDA States that most of these observations arise when office managers review complaints primarily with a customer service focus rather than following a decision tree for reporting decisions to the FDA.

No.1 – Inadequate CAPA Procedures

And in first place, with 377 observations, is a lack of inadequate corrective and preventive action (CAPA) procedures. That is a whopping 37% of the medical device Form 483s in 2015. First place isn’t new for CAPA procedure observations. This is its sixth consecutive year in the top spot and it hasn’t dropped below third place in 10 years.

Of note there is a significant jump in CAPA and complaint 483s in 2011. The FDA speculates that many inadequate CAPA procedure observations originate from smaller companies that are struggling to follow overly complex SOPS. Small companies often purchase “one size fits all” SOPs with intricate procedures that they are not equipped to follow. The FDA suggests that most companies would be better off documenting actual procedures, however simple.

CAPA Chart

And it is not just CAPA procedures that are generating Form 483 observations. A lack of or inadequate CAPA documentation is a valiant runner up to the top 5 most common observations. In 2015, 11% of medical device Form 483s contained CAPA documentation observations and it has made the top 5 list in 8 of the last 10 years.

483 Observations over time chart

As always, a well maintained Quality Management System is crucial to performing well in an FDA inspection. AlvaMed helps our clients streamline and simplify existing systems or develop systems that can grow with the company, are easy to use and pass inspection every time.

Remember to take the time to look over your company’s QMS each year and pay special attention to those top 5 problem areas. Call AlvaMed if you have concerns and would like to discuss how to improve your QMS.

For the most current FDA 21 CFR 820 requirements visit www.ecfr.gov.

For the full listing of the FDA Form 483 observations, go to www.fda.gov/ICECI/Inspections.