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Judgment & ambiguity · When to act

A temperature logger on an already-distributed refrigerated lot reports an excursion in transit, but the data is patchy and you can't tell whether it breached the stability-established range or for how long. Do you initiate a field action now or wait for cleaner data?

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With product already in patients' and pharmacies' hands, the balance of the act-vs-wait call tips toward acting early, but 'act' first means contain and assess, not necessarily recall in the next hour.

The full answer: structure, worked example, likely follow-up.

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