You may find the following information helpful.
- Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
- Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components; Guidance for Industry
- 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)