F ield Alert Reports Sample Clauses

F ield Alert Reports. The manufacturer of a drug subject to an approved new drug application was required to notify FDA in a "Field Alert Report" within three working days of receiving information if the information concerned 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 specification established for it under the drug's approved new drug application. 21 C.F.R. § 314.81(b)(1 )(ii). The Cidra
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Related to F ield Alert Reports

  • Expert Reports Without prejudice to the appointment of other kinds of experts where authorised by the applicable arbitration rules, the tribunal, at the request of the disputing parties, may appoint one or more experts to report to it in writing on any factual issue concerning environmental, public health, safety or other scientific matters raised by a disputing party in a proceeding, subject to such terms and conditions as the disputing parties may agree.

  • Test Reports Should a test report (“Test Report”) be required on the purchase order, the Test Report must be signed or stamped by an authorized representative of the supplier. It must contain, as a minimum, supplier name and address, Buyer part number, purchase order number, quantity, date shipped, heat/lot number, all acceptance criteria for specification and list all of the specifications i.e. MIL-P, AMS, ASTM, etc. which would apply to the shipment. All material shipped is to be the latest revision available. All Test Reports to reference revision level of material shipped.

  • Project Reports 1. The Borrower shall monitor and evaluate the progress of the Project and prepare Project Reports in accordance with the provisions of Section 5.08 of the General Conditions and on the basis of the indicators agreed with the Bank. Each Project Report shall cover the period of one calendar semester, and shall be furnished to the Bank not later than one month after the end of the period covered by such report.

  • COST REPORT 29 A. CONTRACTOR shall submit separate Cost Reports for each Period, or for a portion thereof, to 30 COUNTY no later than forty-five (45) calendar days following the period for which they are prepared or 31 termination of this Contract. CONTRACTOR shall prepare the Cost Report in accordance with all 32 applicable federal, state and COUNTY requirements, GAAP and the Special Provisions Paragraph of this 33 Contract. CONTRACTOR shall allocate direct and indirect costs to and between programs, cost centers, 34 services, and funding sources in accordance with such requirements and consistent with prudent business 35 practice, which costs and allocations shall be supported by source documentation maintained by 36 CONTRACTOR, and available at any time to ADMINISTRATOR upon reasonable notice.

  • Progress Reports The Recipient shall submit to the OPWC, at the OPWC's request, summary reports detailing the progress of the Project pursuant to this Agreement and any additional reports containing such information as the OPWC may reasonably require.

  • Management Reports Promptly upon receipt thereof, copies of all detailed financial and management reports submitted to the Company by independent auditors in connection with each annual or interim audit made by such auditors of the books of the Company.

  • Delinquent Reports The Contractor shall submit required reports by the designated due dates as identified in this Contract. After notice to the Contractor and an opportunity for a meeting with an Agency representative, the Agency reserves the right to withhold payments for services performed under this Contract if the Agency has not received acceptable progress reports, expenditure reports, refunds, and/or audits as required by this Contract or previous contracts for similar or equivalent services the Contractor has entered into with the Agency. This section shall survive any Termination of the Contract or the Expiration of its term.

  • Contract Reporting The Contractor shall report information on orders received from Customers associated with this Contract. No price adjustments will be considered for any Contractor who has outstanding reports, or any other documentation required under this Contract. The Contractor shall submit reports in accordance with the following schedule: Report Period Covered Due Date MFMP Transaction Fee Report Calendar month 15 calendar days after the end of each month Quarterly Sales Report State’s Fiscal Quarter 30 calendar days after close of the period Diversity Report(submitted to the Customer) State Fiscal Year 30 Business Days after close of the period Preferred Pricing Affidavit (in accordance with the Special Contract Conditions) Annual Contract Anniversary Date

  • Daily Reports On each Business Day, the Servicer, with prior notice, shall prepare and make available at the office of the Servicer for inspection by the Trustee a record setting forth (i) the aggregate amount of Collections processed by the Servicer on the preceding Business Day and (ii) the aggregate amount of Receivables as of the close of business on the preceding Business Day.

  • Audit Reports promptly upon receipt thereof, one copy of each other financial report and internal control letter submitted to the Company by independent accountants in connection with any annual, interim or special audit made by them of the books of the Company.

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