Question

Which of the following criteria could lead to a site regulatory inspection/audit?

1) Non-compliance with regulatory requirements
2) Complaints from customers or employees
3) Significant changes in manufacturing processes
4) All of the above

Answer 1

Site regulatory inspections or audits can be triggered by non-compliance, complaints, and significant changes in manufacturing processes.

Step-by-step explanation:

Site regulatory inspections or audits can be triggered by several criteria including:

1. Non-compliance with regulatory requirements: If a site fails to meet the necessary regulations and standards, it may be subject to inspection or audit.
2. Complaints from customers or employees: If there are complaints about the site regarding safety, health, or other issues, it can lead to an inspection or audit.
3. Significant changes in manufacturing processes: When there are major changes in manufacturing processes, it may warrant an inspection or audit to ensure compliance with regulations.

In summary, all of the above criteria can potentially lead to a site regulatory inspection or audit.