Regulatory Open Forum

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  • 1.  1271.220 (b) Pooling

    Posted 14-Nov-2019 09:22

    Has anyone petitioned FDA for an exemption  to  the requirement that human cells or tissues  not be pooled?

    Sec. 1271.220 Processing and process controls.

     (b) Pooling. Human cells or tissue from two or more donors must not be

    pooled (placed in physical contact or mixed in a single receptacle) during

    manufacturing.

    Ann E Kemp
    Regulatory and Quality Services, LLC
    1635 Juno Ave
    St Paul, MN 55116
    612-730-0217


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