A complaint handling system is a procedure for receiving, reviewing and evaluating complaints in a timely manner. According to the Code of Federal Regulations, 21 CFR 820.198, complaint investigations must have the following information:
- Each manufacturer shall maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
- All complaints must be processed in a uniform and timely manner;
- Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting.
- Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
A company was recently cited for:
….. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Specifically, over the last 11 months your firm distributed, your … in the United States. The following deficiencies were noted with your complaint handling system.
a. Your firm has reported and documented zero complaints since it started distribution of the …. However, a review of your complaint handling activities revealed that until 11 months after the start of the distribution the contact phone number, provided in your IFUs, was directed to a commercial phone answering system whose menu included an “Adverse Events” reporting voicemail selection; and that this “Adverse Events” voicemail which was monitored by Marketing Department received two (2) voicemail email notifications, …, with message transcriptions which appear to require further investigation. These two (2) notifications were not forwarded to QA for investigation and evaluation of reportability; and there is no documentation of what follow-up was conducted with the callers to determine if their inquiries constituted complaints.
b. Your procedure SOP …, “Customer Feedback and Complaint Handling”, was inadequate in that the procedure did not include the requirement for complaints to be evaluated to determine whether the complaint is reportable.
For information on a complaint handling system, including medical device complaints and investigations, see FDA Presentations Complaint Files and Complaints and Complaint Investigations.
To view more observations pertaining to medical device complaints, refer to the following GMP Trends® Issues: 1112, 1109, 1108, and 1107.
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