Product Complaints definition

Product Complaints means any report concerning the quality, purity, quantity, weight, pharmacologic activity, labeling, identity or appearance of a Product.
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Product Complaints shall have the meaning set forth in Section 5.7(a).
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Product Complaints means any written, verbal, or electronic expression of dissatisfaction regarding the Licensed Product sold by or on behalf of Licensee (or any of its Affiliates or Sublicensees) in the Field in the Territory, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.
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Examples of Product Complaints in a sentence

  • Product Complaints associated with adverse events will be reported in the study summary.

  • Product Complaints occurring during the study will be followed-up to a satisfactory conclusion.

  • All other Adverse Event reports and Product Complaints must be made within one (1) business day.

  • 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.

  • Product Complaints may require return of the product with the alleged complaint condition (syringe, pen, etc.).

  • The occurrence of adverse events and complaints will be assessed at each study visit and reported to JJSV according to Section 11.0, Adverse Events and Product Complaints.

  • Product Complaints may require return of the product with the alleged complaint condition (syringe).

  • Product Complaints may require return of the product with the alleged complaint condition.

  • Product Complaints concerning the investigational product must be reported to the Sponsor within 24 hours of the study site's knowledge of the event via the Product Complaint form.

  • In performing services or delivering goods, Supplier and its affiliates, representatives or subcontractors may acquire information regarding Adverse Events or Product Complaints related to Elanco’s products.


More Definitions of Product Complaints

Product Complaints. Xxxxxx shall complete product complaint forms provided by UroGen to Xxxxxx and forward any product complaint information to UroGen's post-quality assurance group. UroGen and Xxxxxx will work together to manage product complaints in an effective and responsive manner. Should Xxxxxx or its customers receive significant amounts of defective Products, UroGen will issue to Xxxxxx, or to a customer if directed to do so by Xxxxxx, a refund for such Products, including the cost of return shipment for such Products as well as any associated import/export licenses, fees, customs duties and taxes, or, at Xxxxxx'x option, replacement Products, and the cost of shipping such replacement Products as well as any associated import/export licenses, fees, customs duties and taxes shall be at UroGen's expense.
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Product Complaints means any written, electronic, or oral communication that contains any allegation expressing concern, for any reason, with the quality of a Branded Product that could be related to the Manufacturing practices. Examples of Product Complaints may include but are not limited to: foul odor, off taste, illness or injury, disintegration time, color variation, foreign material in a Branded Product container, improper packaging, mislabeling, Branded Products that contain an incorrect concentration of cannabinoids, or Branded Products that contain an unidentified Ingredient, or any form of contaminant.
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Product Complaints means all information related to product complaints.
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Related to Product Complaints

  • 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.

  • Complaints means each of the following documents:

  • Service Complaints For service problems or complaints, you should contact your local utility by calling: AEP Ohio at 000.000.0000. IN THE EVENT OF AN ENERGY-RELATED EMERGENCY, SUCH AS A POWER OUTAGE OR DOWNED POWER LINE, PLEASE VACATE THE AREA BY A SAFE DISTANCE AND CALL YOUR LOCAL UTILITY or 911. Authorization/Representation/Letter of Agency:By entering into this Agreement, you authorize XOOM to act on your behalf under your local utility’s tariffs in accordance with the rules and regulations of the PUCO. You acknowledge that you are your local utility account holder, or a person legally authorized to execute this Agreement on behalf of the account holder for electricity service and are at least eighteen (18) years of age. You agree to authorize XOOM to obtain your credit information and you agree to authorize your local utility to release all information relating to your historical and current electricity usage, billing and payment history to XOOM or its authorized representatives. You acknowledge that XOOM has full authority to make all rates and tariff selections necessary to meet its obligations under this Agreement. You may rescind this authorization at any time by contacting XOOM. Neither your social security number, customer account number nor any other customer financial information will be released by XOOM, except where such release is required by court order or by Commission Order or Rule, without your affirmative written consent. Execution of this Agreement shall constitute authorization for the release of this information to XOOM.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Environmental Complaint shall have the meaning set forth in Section 4.19(d) hereof.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Recall means any measure aimed at achieving the return of a device that has already been made available to the end user;

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • FDA means the United States Food and Drug Administration.

  • Third Party Data has the meaning set forth in Section 9.3(a).

  • Licensed site remediation professional means an individual who is licensed by the Site Remediation Professional Licensing Board pursuant to section 7 of P.L.2009, c.60 (C.58:10C-7) or the department pursuant to section 12 of P.L.2009, c.60 (C.58:10C-12).

  • Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • Regulatory Agencies The Office of the Comptroller of the Currency; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Federal Housing Finance Agency; the Securities and Exchange Commission; and the Department of Housing and Urban Development.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.