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# FDA Clarifies Field Action Reports Guidance
- URL: https://www.fdaweb.com/fda-clarifies-field-action-reports-guidance/
- Published: 2018-07-26T12:00:00.000Z
- Updated: 2026-09-15T00:22:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141969

Attorney **Jennifer Davidson** (Kleinfeld, Kaplan & Becker) [says](http://www.fdaweb.com/download.php?file=FDA%5FReleases%5FDraft%5FGuidance%5Fon%5FField%5FAlert%5FReport%5Fblog%5Fpost.jad%281%29.pdf) an FDA 7/18 draft question-and-answer guidance on field alert report (FAR) submissions clarifies the circumstances under which a FAR should be submitted. FDA regulations says a FAR should be submitted to the agency within three working days of receipt of any of these types of information: situations in which a drug product may be mistaken for another product; bacterial contamination; any significant chemical, physical, or other change or deteriorations in the distributed drug product; and any failure of a distributed batch of the drug product to meet the specifications established in its application.

The clarification of report submission criteria covers each of the categories and notes that a FAR must be submitted even if the sponsor believes the root cause of the quality defect has been identified and corrected, Davidson says. Also, a recall does not obviate the requirement to submit a FAR.

The guidance says that all drug products marketed under an NDA or ANDA are subject to FAR requirements, including those distributed only outside the U.S.