Query: container closure integrity study methodology

Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0010. Type: deficiency. Risk: medium. Category: Labeling.

Correspondence ID
COR-410
Type
deficiency
Application
MFDS-2020-0010
Authority
Ministry of Food and Drug Safety
Category
Labeling
Risk
Medium
Due Date
2025-01-31
Status
Open
Owner
Marcus Webb
Created
2023-04-12
Correspondence Body
Dear MFDS Review Team, With reference to application MFDS-2020-0010, we wish to address the following: [Detailed response body regarding deficiency letter: missing stability data for 40°c condition] 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_410.xlsxattachment_410_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.