FDA 483 - Emergent Biodefense Operations Lansing LLC - December 12, 2001
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An FDA inspection of BioPort Corporation in Lansing, MI, a biologics manufacturer, revealed several deficiencies related to manufacturing processes and quality control. Observations included incomplete validation of aseptic processes, lack of re-qualification procedures, and issues with validated manufacturing steps. Additionally, the firm lacked adequate written procedures for visual inspection defect limits, software operation, master batch production records, and reagent qualification.
- Inspection Date
- December 12, 2001
- Product Type
- Biologics
ID · a47f076b-5061-41e4-92c1-541ec91dfc30