Glossary
Action Limit
Also writtenaction level
An established criterion which, when exceeded, requires an immediate investigation of the cause and appropriate corrective action.
Source · PIC/S PE 009-17, Glossary, Action limit; MFDS, 「알기 쉬운 GMP 용어집」, Action level Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, there were excursions of the action limit associated with microbial monitoring of personnel in the Grade (b)(4) environment where your products are manufactured.
FDA · FDA Warning Letter · 2024-08-27 -
Your action limits for microbiological monitoring (i.e., active viable air and surface samples) within the critical area (i.e., inside the Biological Safety Cabinet (BSC)) were observed to be greater than (b)(4) colony forming units (CFUs).
FDA · FDA Warning Letter · 2024-08-27 -
However, you did not provide an updated copy of your firm’s environmental and personnel monitoring procedures including microbial sampling, alert/action limits, and routine monitoring activities.
FDA · FDA Warning Letter · 2022-06-14
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Glossary, Action limit; MFDS, 「알기 쉬운 GMP 용어집」, Action level Korean originalGRM Regulatory Glossary
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