Yes. However, as a rule, a CR letter issued without inspections information will not
be counted towards meeting GDUFA performance goals unless a fatal flaw is
identified.
FDA recognizes industry’s preference for prompt communication of any
deficiencies identified during the review process. The Agency may issue a CR
letter identifying deficiencies from all review divisions, if inspections have not yet
been completed, so as not to delay a sponsor’s remediation of identified issues.
