Company: Transplantation Research Foundation
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 disposition activities for unsuitable dura mater [FDA-483 Item 6(a)].
FDA District: Dallas
SoftwareCPR keyword: electronic records