Product Quality Complaint definition

Product Quality Complaint is defined as any complaint that questions the purity, identity, potency or quality of either of the Products, its packaging, or labeling, or any complaint that concerns any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article or any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specifications therefor in the NDA for the Products. Such information shall be sent to WC as set forth in Section 8.2.3
Product Quality Complaint means any complaint alleging a deficiency related to the identity, quality, durability, safety, efficacy or performance of a Private Brand Product, including defects in filling, packaging, labeling or a Product’s physical characteristics (including color or odor).
Product Quality Complaint means an oral or written report, originating from an external or internal source, stating that a product marketed by Medical Imaging is not meeting the customer’s expectations in relation to identity, quality, effectiveness or performance of the product.

Examples of Product Quality Complaint in a sentence

  • For clarification, in the event ▇▇▇▇▇▇▇▇ becomes aware of a Product Quality Complaint, Adverse Event, Other Reportable Information, Field Alert, or other compliance inquiry or investigation with respect to the Product, EVERSANA is only responsible for informing the Third Party that information in respect thereof has been or will be conveyed by ▇▇▇▇▇▇▇▇ to Client.

  • EVERSANA shall cooperate with Client’s reasonable requests and assist Client in connection with Client’s: (i) preparing any and all reports to FDA concerning the Product; (ii) preparing and disseminating all communications to Third Parties concerning the Product; and (iii) investigating and responding to any Product Quality Complaint, Adverse Event, Other Reportable Information, Field Alert, or other compliance inquiry or investigation related to the Product.

  • As between the Parties, Client has the sole responsibility for (i) any statements, whether written or oral, to a Third Party regarding a Product Quality Complaint, Adverse Event, Other Reportable Information, Field Alert, or other compliance inquiry or investigation with respect to the Product, and (ii) taking any action concerning any Regulatory Authority approval under which the Product is sold.


More Definitions of Product Quality Complaint

Product Quality Complaint. (PQC) 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.
Product Quality Complaint means any complaint that questions the purity, identity, potency or quality of the Active Ingredient.
Product Quality Complaint means any and all manufacturing or packaging-related complaints related to the Product, including (a) any complaint involving the possible failure of the Product to meet any of the specifications for the Product and (b) any dissatisfaction with the design,
Product Quality Complaint means any legitimate complaint (as reasonably determined by the Party receiving such complaint) by a Third Party that (a) questions the purity, identity, potency or quality of the Product, its packaging, or labeling, or (b) claims that the Product or its labeling is mistaken for, or applied to, another article or any bacteriological contamination, or (c) claims a significant chemical, physical, or other change or deterioration exists in the distributed drug product, or (d) claims a failure of one or more distributed batches of Product to meet the specifications thereof.
Product Quality Complaint shalt mean any and all Manufacturing or packaging-related complaints from Third Parties related to the Distribution Product, including (a) any complaint involving the possible failure of the Distribution Product to meet any applicable Specifications, (b) any dissatisfaction with the design, package or labeling of the Distribution Product; or (c) any adverse event that may involve the quality of the Distribution Product, including lack of effect, infection, or request for testing.
Product Quality Complaint is defined as any complaint that questions the purity, identity, potency or quality of the Product, its packaging, or labeling, or any complaint that concerns any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article or any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specifications therefor in the NDA for the Product. Such information shall be sent to the same address as set forth in Section 9.3 above. BMS shall be solely responsible for responding to any such Product Quality Complaints.
Product Quality Complaint means any manufacturing and/or packaging-related complaints involving the supplied Finished Product, made by Kangzhe’s customers concerning product quality. A Product Quality Complaint may represent a physical defect in the Finished Product or its packaging, but does not include customer complaints regarding accounts, billing, transportation or shipping.