Day

June 25, 2001
Company: Transplantation Research FoundationDate: 6/25/01 Product Name: Dura mater allografts Failure to establish and maintain procedures to control product that does not conform to specified requirements [21 CFR 820.90]. For example, the computer disposition records did not clearly document the destruction of unsuitable dura mater, and there are no disposition procedures addressing the segregation and...
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