GMP inspection findings clarification
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0065. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-565
Type
question
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Labeling
Risk
Medium
Due Date
2025-02-16
Status
Open
Owner
Nadia Petrova
Created
2022-07-28
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0065, 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
data_table_565.xlsxattachment_565_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.