One of the most common reasons for FDA warning letters is for deficiencies in complaint handling. They typically fall into the following areas:
Inadequate procedures or failing to follow procedures to collect, document and interpret complaints
Inadequate timeliness of closure
Inadequate connection of complaints to reportable requirements
A complaint is any customer dissatisfaction with quality or performance and may include packaging or labeling.
Given that broad definition,...(read more)![]()
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