What is a product complaint?
A written, electronic, or oral notification of a suspected defect in the quality, identity, shelf life, reliability, safety or presentation of a finished medicinal product, or of an accompanying device supplied for its administration, after it has been placed on the market or used in clinical studies.
Examples of product complaints include (but are not limited to):
- Defects in the container and outer packaging
- Defects in labelling or in the package insert
- An unexpected, visually recognizable change in the appearance of the product, container, packaging
- Difficulties in the proper use of the accompanying devices for administering the product
- Incorrect, incomplete or inaccurate materials
You will need to provide the following information to submit the form:
- Product manufacturer and country of complaint
- Product name of the vaccine or medication, Batch / Lot number
- Cause for complaint (defect/event/description of issue)
- Date of occurrence and if the product was administered or not
- Number of units / packages complained and if the sample is available for return?
- Reporter's minimum contact details
- Complainant minimum contact details (if not the reporter) and Consent for follow up
- Pictures of defect if available (up to 3 attachments)
To submit a Product Complaint for product manufactured by CSL Behring, CSL Seqirus, CSL Vifor, complete the form linked below:
Product Complaint Form