Appendix 12 - Deregistration Flow Diagram

This flowchart shows the Deregistration Flow Diagram.

• The process begins with an in-depth inspection and an exit meeting.

If the inspection is unsatisfactory:

• If the in-depth inspection results indicates that public health may be endangered, a letter and report will be issued immediately and a follow up inspection will take place as soon as possible. At the completion of this follow up inspection there will be an exit meeting to discuss the results of the inspection.

  • If the results of this follow up inspection are satisfactory, Directed/Good Manufacturing Practice Inspections will continue as scheduled in the workplans
  • If not, see the directions below.

• If the result of the in-depth inspection is unsatisfactory but does not indicate that public health is endangered, a letter and report will be issued within one week and a follow up inspection will take place within 30 days. At the completion of the follow up inspection there will be an exit meeting.

  • If the results of this follow up inspection are satisfactory, Directed/Good Manufacturing Practice Inspections will continue as scheduled in the workplans
  • If the results of this follow up inspection are not satisfactory both operations and programs are consulted. These consultations can results in:
    • No suspension - further actions or
    • Initiation of suspension. Once suspension is initiated,
      • A notice of suspension is issued by the Director
      • The operator is required to surrender of the certificate of registration
      • A follow up inspection takes place in 30 days (or another agreed upon time).

      * If the follow up inspection is satisfactory, the suspension will be lifted and the certificate of registration will be returned.

      * If the follow up inspection is unsatisfactory a Letter of Intent to Cancel and an Invitation to be Heard is issued by the responsible Inspection Manager. A hearing will be held with two possible outcomes:

      1) The suspension will be lifted and the certificate of registration will be returned. In this case an additional in-depth inspection will take place within one month

      2) There will be a decision to cancel, followed by a Notice of Cancellation issued by the Director

If the in-depth inspection is satisfactory:

• There will be an exit meeting, and the establishment must provide a written corrective action plan addressing all infractions recorded during the inspection. Workplans require regularly scheduled Directed/Good Manufacturing Inspections. During these inspections, the inspector reviews progress being made to correct the identified infractions.

  • If the inspection shows ineffective corrective actions, this is brought to the attention of the establishment at an exit meeting and will result in further follow up.
  • If ineffective corrective actions result in possible public health endangerment there is consultation with operations and programs and the suspension process may be initiated.