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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]
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.
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
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