GMP inspection findings clarification
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0065. Type: deficiency. Risk: medium. Category: Quality.
Correspondence ID
COR-165
Type
deficiency
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Quality
Risk
Medium
Due Date
2025-04-29
Status
In Progress
Owner
Nadia Petrova
Created
2022-12-27
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0065, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-29 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.