Which compliance decision is correct if EM was not performed at the required frequency but results were normal?
QUESTION
Identify the compliance decision when surface sampling shows growth on PEC work surface above action levels.
QUESTION
Identify the compliance decision when ISO classification fails during certification of the PEC.
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ANSWER
Stop sterile compounding until re-certified compliant. Failed ISO certification signals inadequate air quality, requiring cessation of compounding to prevent risks to patient safety until resolved.