FDA Inspections-Complaint Investigation Requirements-Part I

“FDA Inspections-Complaint Investigation Requirements-Part I” is a two-part series that provides an overview of 21 CFR 820.198 requirements. 

Last week, I received a message from someone asking for advice on how to perform a complaint investigation. She has a complaint handling procedure that explains how to determine if complaints are reportable (http://bit.ly/Medical-Device-Reporting), and she is the complaint coordinator. Her procedure includes a list of pre-determined cause codes for the most common complaints the company has received in previous years. Her system does not require a complaint investigation if an existing cause code is identified. She would like to know how to perform an investigation if she receives a complaint that does not fit one of the existing cause codes.

Is It a Complaint?

Most discussions about complaint handling begin with the definition of a complaint [i.e., 21 CFR 820.3(b); http://bit.ly/21CFR820-3]. However, if a complaint is received during an investigation of a device rather than the use of the device, the FDA will still consider this as being “after releasing for distribution.” The reason is that release for distribution occurs at final inspection. If the device breaks during installation, the device was still distributed.

One last question. Is it correct to consider a complaint only when the device is live and not during the settings and installation process of the device? (The definition states “after it is released for distribution,” what do they mean by this?).

What is Required?

The FDA QSR section specific to complaint handling is 21 CFR 820.198 (http://bit.ly/820-198). There are seven subsections (i.e., “A” through “H”) that comprise the regulation.

1. Manufacturers shall maintain complaint files and establish procedures for complaint handling.
2. Manufacturers must review and evaluate if an investigation is needed.
3. Manufacturers must perform an investigation automatically for any complaint involving a device malfunction–unless an investigation has already been performed for a similar complaint.
4. Separate files shall be maintained for complaints that involve adverse events that are reportable under 21 CFR 803 (http://bit.ly/21-CFR-803).
5. The content of a complaint investigation record is specified in this subsection.
6. When the complaint handling unit is located at another facility, the records of investigations shall be reasonably accessible to the manufacturing establishment.
7. When the complaint handling unit is located outside the USA, then the records must be reasonably accessible at a U.S. manufacturer or the location of an initial distributor.

What Does the FDA Expect to See?

FDA inspectors are guaranteed to sample complaint records and CAPA records during every routine inspection. The complaint records sampled will typically be limited to a specific product family that has been selected as the focus of the investigation. Most companies have an electronic log of the complaints, and the investigator may request a sorted list that only includes complaints specific to that one product family. The investigator will already be aware of all of your reported adverse events associated with the product family, and there may be one or two records they specifically want to investigate. The investigator will also review the complaint log to see if there are any complaints with a description that sounds like it might be reportable–even though the complaint was not reported.

The investigator will verify that each complaint record includes the content specified in subsection “E”:

1. name of the device;
2. the date the complaint was received;
3. any device identification(s) and control number(s) used;
4. the name, address and phone number of the complainant;
5. the nature and details of the complaint;
6. the dates and results of the investigation;
7. any corrective action is taken; and
8. any reply to the complainant.

In my response to the question that I received, I also included advice on how to conduct an investigation. In general, the investigation is no different than an investigation for any CAPA. The first step is to perform a root cause analysis. The second part of this article will explain the investigation process in more detail.

Register to receive email notification of new blog postings (http://bit.ly/MDA-Blog), so you can read the second part of this article next week. If you are interested in learning more about complaint handling, you might be interested in downloading the webinar that Medical Device Academy recorded last year for complaint handling and vigilance reporting (http://bit.ly/Complaint-Webinar-Landing). We can also help you one-on-one with a current complaint investigation you are conducting. Please don’t hesitate to contact me and ask for help: Mobile: 802.281.4381 or rob@13485cert.com.