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.
Appears in 4 contracts
Samples: Cell Therapy Manufacturing Agreement (Ortec International Inc), Cell Therapy Manufacturing Agreement (Ortec International Inc), Cell Therapy Manufacturing Agreement (Ortec International Inc)