Authority Inspections Sample Clauses
Authority Inspections. 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. ☐ ☒ ☐
Authority Inspections. Supplier shall notify Client of all regulatory authority inspections that take place at the facility where product is manufactured or the testing laboratory where any of the associated testing is performed. If areas of concern exist which specifically involve any products manufactured for Client, Client should be notified prior to the inspection. In all other cases information on the results of the inspection is appropriate. Such notification will include; · Written notification of any observation, if any, that may impact the manufacture of any products manufactured for Client · Written notification of all related corrective actions and planned completion dates · Any further correspondence with the regulatory authority (if the manufacture of any products manufactured for Client is concerned)
Authority Inspections. In accordance with Section 11.1 of the Manufacturing Agreement, HOVIONE shall notify ACHAOGEN of regulatory inspections that relate to the Product. During the Pre-Approval Inspection (PAI), not more than [***] representatives from ACHAOGEN may be on-site for consultation purposes only (direct
Authority Inspections. In case of inspections at CMS’s premises announced by a competent authority with regard to the Products, CMS shall inform XXXX in due course and allow a representative of XXXX to attend such inspection as far as the inspection relates to Products and their distribution in the Territory.
Authority Inspections. The CONTRACT ACCEPTOR shall notify the CONTRACT GIVER of all regulatory authority inspections that take place at the facility where the SUBSTANCE is manufactured or the testing laboratory where any of the associated testing is performed. If areas of concern exist which specifically involve the SUBSTANCE CONTRACT GIVER should be notified prior to the inspection. In all other cases information on the results of the inspection is appropriate. Such notification will include Written notification of any observation, if any, that may impact the manufacture of the SUBSTANCE Written notification of all related corrective actions and planned completion dates Any further correspondence with the regulatory authority (if the manufacture of the SUBSTANCE is concerned)
Authority Inspections. Authority inspections and tests are for the sole benefit of the Authority and
Authority Inspections. 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.
Authority Inspections. If a Regulatory Authority desires to conduct an inspection or GxP Audit of PTC, its Affiliates, or its or their subcontractors (including CMOs) relating to the Licensed Compounds or Licensed Products, PTC shall promptly (no later than [***] notify Licensee thereof. PTC shall permit Regulatory Authorities to conduct inspections or audits of PTC, its Affiliates, or its or their subcontractors (including CMOs) relating to the Licensed Compounds or Licensed Products, and shall ensure that such Affiliates and subcontractors (including CMOs) permit such inspections and audits to the extent consistent with the terms of any pre-existing contractual arrangement, including any quality agreements. Unless prohibited by Applicable Law, PTC shall permit Licensee to attend and observe the aforementioned inspections or audits as a silent observer. PTC shall provide Licensee with a copy (or detailed written report) of any findings of a Regulatory Authority following a regulatory audit or inspection that are communicated to PTC by such Regulatory Authority, as a result of the inspection or any submitted document(s) or in a correspondence with such Regulatory Authority (e.g., EIR, 483s, warning letters, EMA or European inspection reports, serious breaches, safety urgency measures, issues on PSURs, DSURs, etc.) and corresponding proposed responses, in each case, related to the Licensed Compounds or Licensed Products. In addition, in the event any such inspection could reasonably be expected to have an impact on the patient safety, efficacy or conduct of Clinical Trials of the Licensed Products or PTC’s Data Integrity relating to the Licensed Compounds or Licensed Products, PTC shall, no later than [***] after the date of such inspection (or issuance of the report), provide to Licensee copies of any relevant inspection report or correspondence in PTC’s possession. PTC will reasonably cooperate with Licensee in the preparation of any response to Regulatory Authorities and any corrective action plans which could reasonably be expected to affect PTC’s Data Integrity or be considered critical findings regarding any IND, NDA, MAA or other Regulatory Documentation relevant to the Licensed Compounds or Licensed Products. In the event that any Regulatory Authority desires to conduct an inspection or audit of Licensee relating to the Licensed Compounds or Licensed Products, such as any pre-approval inspection, PTC shall fully cooperate with Licensee upon request in responding to such a...
Authority Inspections. In addition to the Post-Installation Inspection described above, the Acquiring Parties agree to cooperate with the Authority to schedule one inspection and review per calendar year, through 2029, to allow the Authority to observe the Simulator Equipment’s use and review relevant records to aid the Authority in determining the approximate amount of conserved water. The Authority shall be responsible for contacting each Fire Department to schedule the yearly inspections.
Authority Inspections. In case of inspections at KANGZHE’s premises announced by a competent authority with regard to the Products, KANGZHE shall inform XXXX in due course and allow a representative of XXXX to attend such inspection as far as the inspection relates to Products and their distribution in the Territory.