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Requisition form and test report Pathology reports: 10 years [16] Other: 2 years [16] Blood bank records Quality control records: 5 years [15] Donor and recipient records: 10 years [15] Records of indefinitely deferred donors: Indefinite [15] Wet tissues Until report is completed [16] or 2 weeks thereafter [15]
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If the Form 356h is missing information, the FDA will reply within 74 days. [3] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number. Statutory standards for BLA approval are largely the same as those for New Drug Application approval.
A certificate of analysis (COA) is a formal laboratory-prepared document that details the results of (and sometimes the specifications and analytical methods for) one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses. This document gives assurances to the ...
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