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Five Ways to Prevent Complaint Handling Pitfalls


Continue learning
from Rob Packard
at OMTEC 2014

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The best way to avoid receiving 483s is to learn from the mistakes of others. Therefore, this article analyzes each of the five most common 483s related to 21 CFR 820.198. For each of these five inspection observations, we’ll learn what FDA inspectors typically find that results in a 483. We will also describe what FDA inspectors hope to find.

Medical Device Academy’s data analysis of FDA inspection reports for FY2013 identified that there are actually 15 individual citations related to complaint handling that FDA is using from the TURBO EIR System. In aggregate, these 15 citations represent more than ten percent of the total Form 483s issued in FY2013. The table at the bottom of the page summarizes the frequency of these 15 regulatory clauses.

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“Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically…”—21 CFR 820.198(a)

This is the most frequently issued 483 observation for the complaint handling process, because complaint handling procedures are poorly written and often missing important requirements. Complaint handling requirements are prescriptive. Anyone responsible for reviewing and approving the complaint handling procedure should be trained on the requirements for complaints, and at least one person should review each of the seven subsections (i.e., a, b, c… and g) to ensure that every requirement is addressed by the procedure. This only needs to be done for the initial release of the procedure, or when there is a major rewrite of the procedure. However, it must be done—or
you may be receiving this 483 in FY2014.

In addition to ensuring that the procedure includes all requirements from 21 CFR 820.198, you must also ensure that the procedure provides adequate detail to explain how the requirements will be implemented for your company. To ensure that a procedure does this, I recommend the following approach. First, create a two-column table. Record each requirement in the left-hand column. Then ask each person responsible for complaint handling to explain how the requirement is met. Each should provide a reference to the section of the complaint handling procedure in the right-hand column to indicate where the requirement is addressed in the procedure. If one of the rows is completed incorrectly, it could mean that this person needs retraining. If multiple people make the same mistake, your training may not be effective, or your procedure may need to be written more clearly.

If your company is considering use of a software system for complaints, you may want to perform the above exercise during the software demo. If the software was not specifically developed for medical device complaint handling, you may find that some of the requirements are not clearly met. In this case, if you select the software, you may have to provide specific instructions on how to “work around” its deficiency.


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