We perform a required quality assurance test more frequently than stated in the regulations. If the results of this test lie outside the regulatory action limits, must we take corrective actions based on this test or can we wait until the test is repeated at its regularly scheduled time?
Regardless of when it is performed, if the facility documents that the results of a required quality assurance test lie outside the regulatory action limit, the facility must take the appropriate corrective action(s) within the specified regulatory time frame. 21 C.F.R. 900.12(e)(8).
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