When facilities are cited for the STEP test, what corrective actions by the facility are deemed adequate?
First, if the STEP test fails, the inspector should repeat the test for verification. If the STEP test fails again, the facility will need to respond to FDA or the Certifying State Agency. Any subsequent action by the facility that results in a documented improvement in its processing will be considered an adequate response. The facility may use the process described in Reference Information for Facilities – the STEP Test found elsewhere in the PGHS to determine whether the processing speed has returned to acceptable limits. The following tests should not be done by the inspector, but are rather the responsibility of the facility.
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