Materials Procured bv Fresenius Sample Clauses

Materials Procured bv Fresenius. Fresenius is responsible for auditing and qualifying vendors of actives, raw materials and components used in PRODUCTS and will provide TransMedics with a Certificate of Conformance statement for such vendors when requested. Fresenius will audit raw material vendors/suppliers at regular intervals according to a defined program. The identity of the vendors/suppliers audited, the date of audit and final audit reports will be available for review by TransMedics upon request. Fresenius is responsible for ensuring that all materials and components procured by Fresenius for use in the PRODUCTS are in compliance with the Material Specifications. Raw materials are given a retest date upon the satisfactory completion of all initial testing. Re-testing will be performed at defined time intervals to ensure the chemical and physical stability of the raw materials. TransMedics shall provide the FDA approved text for all labeling materials (including package insert). TransMedics may request revisions to labeling as they determine needed. TransMedics will maintain original documentation according to record retention procedures consistent with FDA requirements. Fresenius will maintain a file documenting TransMedics’s approval of printers’ proofs.
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