You may find the following information helpful.
Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule
Biological Products: Reporting of Biological Product Deviations in Manufacturing (Final Rule)