15: Reviewing your response and closeout

The closeout process is intended to ensure the manufacturer commits to perform appropriate CAPAs for each deficiency within an acceptable time period. The closeout correspondence records this commitment as well as our comments and agreement.

The scope of the closeout is limited to the list of deficiencies in the PIL. We will consider closing out the inspection after we have reviewed your responses to the deficiencies in the PIL.

The length of time that it takes to close out an inspection depends on whether you propose suitable CAPAs that address our concerns.

• We will usually review your initial response within four weeks of receiving it.
• If we need additional information, we will notify you and specify a due date.
• You will have up to two opportunities to submit subsequent responses.

If, after your third response, your responses are unacceptable, the inspection may be referred to a review panel.