Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-51

https://www.fda.gov/media/108969/download




"If the application is deficient in some material sense such that the firm would have to put forth significant effort to address the deficiency, e.g., an additional clinical study or substantial manufacturing changes or the firm would need at least a year or more to correct deficiencies, the review committee may decide that the inspection should be postponed until the applicant has submitted information to address the deficiency. The Director, DMPQ, or Director, DBCD (for BPB products), and the Director, product division, should concur in the decision to postpone the inspection. In this case, a complete response letter may be issued without an inspection having been performed. The complete response letter should inform the applicant that because of the length of time anticipated to correct the deficiencies, CBER will not perform an inspection until the applicant submits information that appears to address the deficiencies."