As License holders or reg experts, we all know what Health Canada inspections are, how to prepare, different types of observations, and inspection ratings. However, few of us know how inspectors decide what enforcement measures to take when non-compliance is observed.
If Health Canada inspectors notice that regulated parties (for instance, License Holders) are unable or unwilling to take actions against non-compliance, they are going to act. Those actions could be issuing warning letters, seizure of products, revoking license permits, fines up to $1 million, recall of the product, and others.
Health Canada inspectors will decide what enforcement actions to take depending on a few key decision factors:
– Public health and public safety risk
– The behavior of regulated party
– Compliance history
– Other factors, such as the likelihood of the same problem occurring
Being aware of these decision factors is a critical aspect while preparing for an inspection. For instance, License Holder should cooperate with the inspector and should not behave in a reckless manner, thus, showing good behavior. I have seen clients getting warning letters and product seizures several times.
It is also important to review your last inspection reports and take corrective actions in a timely manner to avoid escalating your observation ratings. For instance, an observation rated as minor could turn into a major if not resolved in the following inspection.
We at CanSat Consulting are not superficial experts; we dig deeper into regulations to ensure our clients are protected and fully compliant.
Contact us today at info@cansatconsulting.com to schedule a no-obligation complimentary consultation with one of our experts.