KBI Biopharma, Inc. – FDA 483, Apr 1, 2026

KBI Biopharma Inc. in Durham, NC, a drug substance manufacturer, received an FDA Form 483 citing significant quality system deficiencies. Observations included inadequate environmental controls in ISO 5 areas, failure to follow validated monitoring procedures, and insufficient investigation and documentation of invalid assay results. The firm also failed to maintain proper chain of custody for samples, adequately address deviations with effective CAPAs, and perform required annual product quality reviews.