FDA Warning Letter definition

FDA Warning Letter means that certain Warning Letter issued to Seller by the FDA on November 25, 2014.
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FDA Warning Letter has the meaning assigned to such term in Section 3.21(a).
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FDA Warning Letter means, with respect to any Person, a Warning Letter to such Person from the FDA or U.S. Department of Health and Human Services, as the case may be.
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Examples of FDA Warning Letter in a sentence

  • SUPPLIER shall promptly notify CUSTOMER of any regulatory or cGMP violations (e.g. FDA Warning Letter or suspension/withdrawal of one or more CEPs) identified during authority GMP inspections and impacting the quality of PRODUCT intended to be shipped to CUSTOMER and/or potentially affecting the ability of SUPPLIER to produce or ship the PRODUCT.

  • Supplier shall provide Distributor with a copy of any written or electronic communication that it receives from FDA or any other governmental authority that threatens or seeks enforcement action, including, but not limited to, a voluntary or mandatory recall, detention, seizure, injunction, prosecution, or civil fines, and is reasonably related to the Products covered by this Agreement (e.g. an FDA Warning Letter).

  • FDA Warning Letter update detailing key issues, action plan update, key tasks accomplished, tasks past due and copies of all FDA communications Monthly 15th following month 8.

  • In the event KING receives an FDA Warning Letter related to _____________, KING will, within two business days of receipt, inform _________________ in writing and by telephone, providing the details associated with the cause of the warning letter.

  • Criteria for Supplier Quality Agreement Establishing a Medical Device Security Program Panel Discussion FDA Warning Letter FDA Enforcement FDA Interaction.

  • CUSTOMER and VENUSA shall mutually inform each other of any written or electronic communication that it receives from FDA or any other governmental authority that is reasonably related to the Products covered by this Agreement, including a FDA Warning Letter, in which FDA or any other governmental authority seeks or threatens to seek enforcement action, including, but not limited to, a voluntary or mandatory recall, detention, seizure, injunction, prosecution, or civil fines.

  • Criteria for Supplier Quality Agreement Establishing a Medical Device Security Program Panel Discussion FDA Warning Letter FDA.

  • In the event _____________ receives an FDA Warning Letter related to ____________, ___________ will, within two business days of receipt, inform ______________ in writing and by telephone, providing the details associated with the cause of the warning letter.

  • Euticals shall promptly notify CMS of any regulatory or cGMP violations (e.g. FDA Warning Letter or suspension/withdrawal of one or more CEPs) identified during authority cGMP inspections and impacting the quality of the SUBSTANCE intended to be shipped to CMS and/or potentially affecting the ability of Euticals to produce or ship the SUBSTANCE.