Transcription of Complaints and Complaint Investigations
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Complaints and Complaint Investigations
Complaints and Complaint InvestigationsPresented by:Graham N. Giesen, Supervisory InvestigatorFood and Drug AdministrationOffice of Regulatory AffairsDallas District OfficeDefinition: ComplaintAny written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution21 CFR (b) Complaint Files & procedures Maintain Complaint files Establish and maintain procedures for receiving, reviewing, and evaluating Complaints by a formally designated unit Process all Complaints in a uniform and timely manner Document oral Complaints upon receipt21 CFR (a)
Complaint Files & Procedures • Maintain complaint files • Establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally
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