An investigation is not required for every complaint. However, there are four cases that require an investigation, not three. 820.198(d) includes, "Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified."Often, there is confusion between complaint evaluation and complaint investigation. The evaluation requirement is in 820.198(b), "Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary".The QSR preamble, section 190 clarifies. "Section 820.198(b) discusses the initial review and evaluation of the complaints in order to determine if complaints are 'valid'. It is important to note that this evaluation is not the same as a complaint investigation. The evaluation is performed to determine whether the information is truly a complaint or not and to determine whether the complaint needs to be investigated or not."The requirement is to evaluate all complaints but investigate a subset.
Determining Whether An Investigation Is Necessary - 21 CFR 820.198(b)
The firm should evaluate complaints thoroughly to determine whether an investigation is necessary. Indicators that the firm may not be in compliance would be shown by:
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