GMP inspection findings clarification
Correspondence from Food and Drug Administration regarding FDA-2024-0081. Type: question. Risk: high. Category: Administrative.
Correspondence ID
COR-481
Type
question
Application
Authority
Food and Drug Administration
Category
Administrative
Risk
High
Due Date
2025-03-31
Status
In Progress
Owner
Nadia Petrova
Created
2023-08-02
Correspondence Body
Dear FDA Review Team,
With reference to application FDA-2024-0081, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_481.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.