GMP inspection findings clarification
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0007. Type: deficiency. Risk: high. Category: Labeling.
Correspondence ID
COR-207
Type
deficiency
Application
Authority
Therapeutic Goods Administration
Category
Labeling
Risk
High
Due Date
2024-12-06
Status
Overdue
Owner
Sarah Chen
Created
2023-07-27
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0007, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_207_1.pdfdata_table_207.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.