Product complaint 2025

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A product complaint is any inquiry or dissatisfaction with the identity, strength, quality or purity of a pharmaceutical product or medical device, including reports of suspected counterfeit/falsified product.
It defines complaints, lists types of complaints (critical, major, minor), and sources of complaints (internal, external, verbal, written).
Information To Include in Your Letter Give the basics. Tell your story. Explain how you want to resolve the problem. Describe your next steps. Send your complaint letter. [Your Mailing Address] [Your City, State, Zip Code] [Your email address]
Quality complaints can include: Abnormal odour or taste. Inaccurate or unreadable product labels/labelling (including the package insert) Capsule leakage. Packaging that is torn or punctured.
iii) Product Quality Complaint: Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a product after it is released for distribution. (
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an abnormal laboratory finding), symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Product Complaint means any alleged failure of a product, including identity, durability, reliability, safety, efficacy or performance.

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