Observations related to complaint file handling make up a significant portion of 483 findings and Warning Letter observations for Medical Devices. In the 483 data released by the FDA for 2012 Device inspections, out of 1090 issued 483s, there are over 400 observations for different sections of 21 CFR 820.198, the regulations dealing with complaint files.
Chapter 15 of the FDA Compliance Guide “Medical Device Quality Systems Manual” provides a detailed discussion of what is involved in complaint handling, and important things to consider when integrating these procedures into a Quality System. A proper complaint system details the formal processes involved with gathering complaints from the various sources, and investigating the cause. This investigation procedure should feed into a Corrective and Preventive Action (CAPA) procedure, as well as a Medical Device Reporting (MDR) procedure. The requirements for CAPA and MDR are detailed in 21 CFR 820.100 and 803, respectively.
The FDA expects device companies to proactively monitor all possible sources of complaints. A complaint is defined as “…any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” Some of these complaint sources are obvious, such as an end user or health professional calling or emailing about an issue they are having with a product. Others may not be so obvious. For example, the FDA expects that any events detailed in scientific articles and other such literature related to the device in question should be considered as sources of complaints.
Of all the observations related to Complaint Files, the most frequently issued (~24%) is “Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.” This is the type of observation received by companies with serious gaps in their procedures. The most common deficiency in complaint handling procedures is the investigation process. It is important to conduct a thorough evaluation of all incoming complaints; using the appropriate six sigma tools can help produce detailed, meaningful results.
The other observation related to complaint files that frequently appears (~7%) in 483s is “Complaint files are not [adequately] maintained.” As with any other quality process, comprehensive and detailed documentation is highly important. Quality records should have leave a clear trail from the initial receipt of a complaint, through the investigation and CAPA process, all the way to final comments regarding ongoing monitoring of the issue as necessary. The FDA has provided a sample procedure and form for recording such information.