Fda blood bank inspection checklist 2025

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Per FDA requirements, all HCT/P donors must be tested for the following infectious diseases: HIV, types 1 and 2; HBV; HCV; and Treponema pallidum.
Under 21 CFR 606.171, you are required to report certain events associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution of blood or a blood component, which may affect the safety, purity, or potency of a distributed product.
Each label must have at a minimum: (A) A unique facility identifier; (B) Lot number relating to the donor; (C) Product code; and, (D) ABO and Rh of the donor.
The FDAs bar code rule does not specify which language should be used, only that machine-readable information must be available. Each label must have information that contains, at a minimum, a unique facility identifier, a lot number relating to the donor, a product code, and the ABO and Rh of the donor.
Required Packaging Elements and Placement Statement of Identity. Net Quantity of Contents. Nutrition Facts Label. Ingredient Statement. Allergen Declaration. Name and Address of the manufacturer, packer, or distributor. Additional Packaging Elements. Nutrient Content Claims.
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All samples MUST be labelled with the following information: Full Name - Surname and First name (click here if the patient is unknown) Patient Identification number (Please note that if a Hospital Unit Number is present this must be given priority) Date of Birth. Ward/Location. Gender. Date and Time of sample collection.
Check if your patient has given informed consent. Complete the blood component prescription and blood request form. Collect pretransfusion specimen after accurately confirming patients identity. Verify that request form and sample carry the same patient identification information.
Each label must have information that contains, at a minimum, a unique facility identifier, a lot number relating to the donor, a product code, and the ABO and Rh of the donor.

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