US FDA
21 CFR 314.81(b)(1) - Field Alert Report Requirements
Plain-language explanation, inspection context and common violation patterns.
What it says
Applicants must submit a Field Alert Report within three working days of receipt of information concerning any distributed drug product that may not meet its approved specifications, may be subject to mix-up, contamination, or otherwise presents a significant chemical, physical or other quality problem.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- The three-day clock starts at the moment information suggesting a possible problem becomes known, not once an investigation has confirmed the problem is real.
- A Field Alert Report addresses product quality issues specifically, and operates independently of adverse event reporting obligations, which address patient safety outcomes through a separate pathway.
- The trigger can come from any source: a customer complaint, an internal stability result, an OOS finding, or an observation during routine monitoring, provided it concerns already-distributed product.
What FDA inspectors look for
- The gap between the date information suggesting a possible specification failure was first known internally and the date the Field Alert Report was actually filed.
- Whether the firm's internal procedures correctly define the triggering event as awareness of information, rather than as the conclusion of root cause investigation.
- Whether Field Alert Reports are filed consistently across similar triggering events, rather than being filed only when a formal investigation happens to conclude quickly.
Most common violation
Waiting for the internal investigation or root cause determination to conclude before filing, rather than filing within three calendar days of the triggering information itself becoming known. This single misunderstanding, that the clock starts at confirmation rather than at awareness, is the most common Field Alert Report timing failure.
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