Inspections by Regulatory Agencies. CBSW will allow representatives of any regulatory agency to inspect the relevant parts of the Facility where the manufacture of the Product is carried out and to inspect the Master Production Record and Batch Records to verify compliance with cGMP and other practices or regulations and will promptly notify Client of the scheduling of any such inspection relating to the manufacture of Product. CBSW will promptly send to Client a copy of any reports, citations, or warning letters received by Client or by CBSW in connection with an inspection of a regulatory agency to the extent such documents relate to or affect the manufacture of the Product.
Inspections by Regulatory Agencies. LONZA shall allow representatives of any Regulatory Authority to inspect the relevant parts of the Facility where the manufacture or supply of a Product is carried out and to inspect the Master Production Record and Batch Records to verify compliance with Applicable Laws and other practices or regulations and shall cooperate with such Regulatory Authority with respect to such inspections and any related matters. LONZA shall promptly notify CLIENT of the scheduling of any such inspection relating to the manufacture and supply of Product and shall keep CLIENT informed about the results and conclusions of each such regulatory inspection relating to a Product, including actions taken by LONZA to remedy conditions cited in such inspections. In addition, LONZA shall allow CLIENT or its representative to assist in the preparation for and be present at such inspections relating to a Product. LONZA will promptly send to CLIENT a copy of any reports, citations, warning letters, or other correspondence received by LONZA from any Regulatory Authority, including, but not limited to, FDA Form 483, Notices of Observation, and all related correspondence, to the extent such documents relate to the Product, its manufacture or general manufacturing concerns applicable to Products (including facility compliance or the like). Prior to responding to any reports, requests, directive or other communications issued by any Regulatory Authority relating to a Product or its manufacture, to the extent practicable, LONZA shall provide CLIENT a copy of its proposed response for CLIENT’s review and comments and LONZA shall take under careful consideration and use good faith efforts to implement any comments or recommendations provided by CLIENT with respect thereto prior to submitting such response to the applicable Regulatory Authority.
Inspections by Regulatory Agencies. 1.1 Patheon shall inform Reliant Pharmaceuticals of any Regulatory Agency performing an inspection of the drug product, or a facilities inspection affecting the drug product within the same business day of notification. Reliant Quality Department may be present at any drug product specific inspections and exit meetings.
1.2 All drug product specific regulatory correspondence, or facilities correspondence affecting the manufacturing of the drug product shall be conveyed to Reliant Quality Department within 2 business days of receipt. Patheon shall provide written responses to all drug product related observations for Reliant review prior to commitment to any regulatory authority.
1.3 Patheon shall provide copies of all regulatory agency inspection documentation (i.e. 483’s, EIR’s, etc.) or any other regulatory correspondence pertaining to the drug product to Reliant Quality Department within two business days of receipt. A redacted copy may be provided to protect other customer’s products.
Inspections by Regulatory Agencies. 1.1 Cardinal shall inform Reliant Pharmaceuticals of any Regulatory Agency performing an inspection relating to the Product, or a facilities inspection affecting the Product within the same business day of notification. Reliant Quality Department may be present at any Product specific inspections and exit meetings with prior approval from Cardinal’s Quality Department.
1.2 All Product specific regulatory correspondence, or facilities correspondence affecting the manufacturing of the Product shall be conveyed to Reliant Quality Department within 2 business days of receipt. Cardinal shall provide written responses to all Product related observations for Reliant review prior to commitment to any regulatory authority.
1.3 Cardinal shall provide copies of all regulatory agency inspection documentation (i.e. 483’s, EIR’s, etc.) or any other regulatory correspondence pertaining to the Product to Reliant Quality Department within seven business days of receipt. A redacted copy will be provided to protect other customer’s products.
Inspections by Regulatory Agencies. Except as otherwise set forth in the Quality Agreement, LONZA will allow representatives of any regulatory agency to inspect the relevant parts of the Facility where the manufacture of the Product is carried out and to inspect the Project Documentation and Batch Records to verify compliance with cGMP and other practices or regulations and will promptly notify CLIENT of the scheduling of any such inspection relating to the manufacture of Product. LONZA will promptly send to CLIENT a copy of any reports, citations, or warning letters received by LONZA in connection with an inspection of a regulatory agency to the extent such documents relate to or affect the manufacture of the Product.
Inspections by Regulatory Agencies. CBSW will allow representatives of any regulatory agency to inspect the relevant parts of the Facility where the manufacture of the Product is carried out and to inspect the Master Production Record and Batch Records to verify compliance with cGMP and other practices or regulations and will promptly notify Clients of the scheduling of any such inspection relating to the manufacture of Product. CBSW will promptly send to Clients a copy of any reports, citations, or warning letters received by CBSW in connection with an inspection of a regulatory agency to the extent such documents relate to or affect the manufacture of the Product. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
Inspections by Regulatory Agencies. LWI will allow representatives of any regulatory agency to inspect the relevant parts of the Facility where the manufacture of the Product is carried out and to inspect the Master Production Record and Batch Records to verify compliance with cGMP and other practices or regulations and will promptly notify CLIENT of the scheduling of any such inspection relating to the manufacture of Product. LWI will promptly send to CLIENT a copy of any reports, citations, or warning letters received by CLIENT in connection with an inspection of a regulatory agency to the extent such documents relate to or affect the manufacture of the Product.
Inspections by Regulatory Agencies. 1.1 Abbott shall inform Reliant Pharmaceuticals of any Regulatory Agency performing an inspection relating to the Product(s), or a facilities inspection affecting the Product(s) within the same business day of notification. Reliant Quality Department may be present at any inspections and exit meetings specific to the Product(s).
1.2 All Product(s) specific regulatory correspondence, or facilities correspondence affecting the manufacturing of the Product(s) shall be conveyed to Reliant Quality Department within 2 business days of receipt. Abbott shall provide written responses to all Product(s) related observations for Reliant review prior to commitment to any regulatory authority.
1.3 Abbott shall provide copies of all regulatory agency inspection documentation (i.e. 483’s, EIR’s, etc.) or any other regulatory correspondence pertaining to the Product(s) to Reliant Quality Department within two business days of receipt. A redacted copy may be provided to protect other customer’s products.
Inspections by Regulatory Agencies. 1.1 Shasun shall inform Reliant Pharmaceuticals of any Regulatory Agency performing an inspection relating to the Product(s), or a facilities inspection affecting the Product(s) within two business day of notification.
1.2 All Product(s) specific regulatory correspondence, or facilities correspondence affecting the manufacturing of the Product(s) shall be conveyed to Reliant Quality Department within 2 business days of receipt. For any response specific to a Reliant Product, Shasun shall provide written responses to observations for Reliant review prior to commitment to any regulatory authority.
1.3 Shasun shall provide copies of all regulatory agency inspection documentation (i.e. 483’s, EIR’s, etc.) or any other regulatory correspondence pertaining to the Product or facility to Reliant Quality Department within two business days of receipt. A redacted copy may be provided to protect other customer’s products.
Inspections by Regulatory Agencies. Each Party will promptly notify the other Party if any regulatory agency inspects its facility and such inspection is related to the manufacture and supply of the Product or manufacture of Generic Tussionex. Each Party will allow representatives of any regulatory agency to inspect the relevant parts of its facility where any activities conducted hereunder with respect to the manufacture and supply of Product or manufacture of Generic Tussionex are carried out and to inspect any documentation, reports and batch records to verify compliance with cGMP and other practices or regulations and will promptly notify the other Party of the scheduling of any such inspection. Each Party will promptly send to the other Party a copy of any 483 observations, warning letters, or consent decrees received by such Party in connection with an inspection by a regulatory agency that is related to the manufacture and supply of the Product or manufacture of Generic Tussionex. To the extent such 483 observation, warning letter or consent decree to one Party directly impacts its ability to supply Product (in the case of CPI) or manufacture Generic Tussionex (in the case of Neos), the affected Party will notify the other Party and allow such Party to participate, to the extent practicable, in a proposed response. After the filing of a response with any regulatory agency, the responding party will notify the other Party of any further written contacts with such regulatory agency relating to the subject matter of the response.
