Product Complaint definition

Product Complaint means any oral, electronic or written communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a marketed product, including failure of the product, labelling or packaging to meet specifications, whether or not the product is related to or caused the alleged deficiency. A complaint may allege that an Adverse Event or Medical Device Malfunction (as defined herein) has occurred.

Product Complaint means any written, verbal, or electronic expression of dissatisfaction regarding Product including, but not limited to, actual or suspected product tampering, contamination, mislabeling, or wrong ingredients.

Product Complaint means any Information that comes to the attention of either Party, its Affiliates or its sublicensees, concerning any dissatisfaction regarding a Product of such a nature and magnitude that it is required under the Applicable Law to be collected, maintained and reported to a Regulatory Authority, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

Examples of Product Complaint in a sentence

• A Product Complaint is a customer's written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a Lilly product/device after it is released for distribution.

• All defects will be communicated to MedImmune and investigated further with the Product Complaint Department.

• Product Complaints concerning the investigational product and/or device must be reported to the Sponsor within 24 hours of the study site's knowledge of the event via local Product Complaint reporting practices.

• Information included in the Product Complaint record shall at a minimum include date; name, title and address of complainant; product name and serial or lot number; description of the event; and if a potential adverse event any clinical impact.

• If a drug shipment arrives damaged or if there are any other drug complaints, a Product Complaint Form should be completed and emailed to the Sponsor or the Sponsor’s representative.

More Definitions of Product Complaint

Product Complaint means any written, verbal or electronic expression of dissatisfaction regarding the Product, including without limitation reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

Product Complaint means any expression by a Third Party of dissatisfaction relating to the identity, durability, reliability, safety, efficacy or performance of any Product, including actual or suspected product tampering, contamination, mislabeling or misformulation.

Product Complaint means all data, which come to the attention of either Party, its Affiliates or its sub-licensees, concerning any dissatisfaction regarding a Product of such a nature and magnitude that it is required under Applicable Laws to be collected, maintained and reported to a Regulatory Authority, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

Product Complaint has the meaning set forth in Section 5.6.

Product Complaint means any complaint or inquiry (either written or verbal) from any source that is related to the Products.

Product Complaint means notification relating to product quality, purity, identity, potency, packaging, tampering, and/or quality aspects of the Product.

Product Complaint means a customer’s written, oral, or electronic communication that alleges deficiencies related to the identity, quality, safety, purity, durability, reliability, safety, effectiveness, or performance of a distributed product, drug/device combination product, animal health premix, active pharmaceutical ingredient, process intermediate, or fermentation product.