14: Addressing deficiencies

We normally give you up to four weeks to submit a written response to the inspection findings, which usually equates to a total of eight weeks from the end of the inspection. However, if we identify serious or significant compliance issues, we may give you less time.

You need to complete the manufacturer closeout record following the instructions outlined in the PIL. We will provide you with an electronic template for this record; you do not have to use the template but you may find it helpful.

Your response should clearly outline the actions you will take to correct any deficiencies we have identified. In responding you should:

• develop a corrective and preventative action (CAPA) plan for all critical and major deficiencies identified. This plan must include:
  • an investigation of the root cause of all critical and major deficiencies
  • details of the corrective action(s) to address the root cause
  • details of the preventative action(s) to address the root cause
  • corrections to address the deficiency examples
  • the date all actions will be complete
• for deficiencies classified as 'other', provide the response date, the correction(s) to be applied and when they will be completed

Implement all actions in response to deficiencies as you have described in your response. You need to correct any deficiencies identified at a new manufacturing site before a licence or certification can be granted.

Objective evidence

You must record and review any actions taken to address deficiencies but you do not need to submit objective evidence of these unless expressly requested to. We will assess the effectiveness of the actions taken at the next inspection.

We may request objective evidence where warranted, for example where we find significant noncompliance at an initial inspection, or where we identify chronic noncompliance.