The number of medical device quality system (QS) surveillance inspections and warning letters decreased in 2013, according to the Center for Devices and Radiological Health (CDRH). The Center released the annual data as part of the FDA Transparency Initiative and Case for Quality, a report intended to improve device quality by addressing common inspection observations and offering areas of concern to help device companies avoid warning letters. The data tracked findings from January 1 to December 31, 2013.
Key findings from inspectional observations:
- The amount of inspectional observations decreased by 17 percent in 2013 vs. 2012.
- The amount of QS surveillance inspections decreased 3 percent from 2012-2013. This is likely due to an increase in the proportion of foreign inspections performed, which require more agency resources.
These three steps can assist in preventing mistakes when FDA does show up for an inspection:
- Be responsive.
- Don’t say too much.
- Know what documentation you need, and have it ready.
The most common observations found in 2013 were:
- Corrective and preventive action procedures (CAPA)
- Complaint files in regard to establishing and maintaining procedures for receiving, reviewing and evaluating complaints
- Quality audits in regard to assuring that a QS is in compliance with the established QS requirements and to determine the effectiveness of a QS
In 2013, 3,534 FDA Form 483 observations were cited for 21 CFR 820 (QS regulation) deficiencies. The table below details those observations.
|QS Subsystem||# of Observations||Percentage|
|Production and Process Controls (P&PC)||1,151||33%|
|Corrective and Preventive Actions (CAPA)||1,085||31%|
|Management Controls (MGMT)||425||12%|
|Design Controls (DES)||506||14%|
|Document Controls (DOC)||367||10%|
How can you avoid and address complaints? Learn from others’ mistakes. Here are strategies for successfully handling the most common complaint.
Key findings from warning letters:
- The amount of warning letters decreased from 164 in 2012 to 144 in 2013, the first decrease since 2009
- Four percent of domestic firms inspected received warning letters
- 16 percent of foreign firms inspected received warning letters
- The three most common warning letter citations were regarding:
- Complaint files
- Quality audit procedures
If you receive a warning letter, corrective action must be taken, and you should make a formal response to FDA within 15 business days (unless otherwise stated). Prepare for your reply to FDA by using this example of a warning letter and response strategy.
Access the 2013 Annual FDA Medical Device Quality System report for a complete breakdown of each QS subsystem’s inspectional observations and warning letter citations, as well as historical trend data.
|For more on how to avoid making quality mistakes:
Corrective and Preventive Action: What does FDA Look for During Inspection?
Strategic Planning for Regulatory Compliance
Design Control Hot Buttons to Expect During an FDA Inspection