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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.198
Apr 01, 2019 · (c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=211.198
Apr 01, 2019 · (a) Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an ...
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https://www.law.cornell.edu/cfr/text/21/820.198
21 CFR § 820.198 - Complaint files. ... Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. ... (c) Any complaint involving the …
https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/
Mar 21, 2017 · Applicable Regulatory Requirements: The complaint-handling procedure should be compliant with applicable regulatory requirements. For example, the Food and Drug Administration (FDA) governs regulatory requirements in the United States, and its 21 CFR section 820 is a designated regulation for medical device manufacturers and suppliers.
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https://www.fda.gov/media/109411/download
Learn about the mechanisms of complaint files and continual postmarket role 3. Understand the contribution that complaint files have ... 21 CFR 820.198(c) • Any alleged complaint involving ...
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https://law.justia.com/codes/tennessee/2010/title-4/chapter-21/part-1/4-21-101/
2010 Tennessee Code Title 4 - State Government Chapter 21 - Human Rights Part 1 - General Provisions 4-21-101 - Purpose and intent. 4-21-101. Purpose and intent. (a) It is the purpose and intent of the general assembly by this chapter to:
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