Query: container closure integrity study methodology

Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0059. Type: deficiency. Risk: medium. Category: Labeling.

Correspondence ID
COR-059
Type
deficiency
Application
Roszdravnadzor-2021-0059
Authority
Ministry of Health of Russia
Category
Labeling
Risk
Medium
Due Date
2025-03-03
Status
Draft
Owner
James O'Brien
Created
2023-05-10
Correspondence Body
Dear Roszdravnadzor Review Team, With reference to application Roszdravnadzor-2021-0059, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] 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: 2025-03-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.