FDA 483 - KBI Biopharma, Inc.
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of KBI Biopharma, Inc. in Durham, North Carolina, revealed significant deficiencies in the temperature qualifications of their GMP ambient storage areas. Critical materials, including resins for Drug Substance Intermediate (DSI) production, microbial testing materials, and reagents for characterization, were found stored in unqualified ambient conditions. This indicates a serious lapse in maintaining appropriate environmental controls for sensitive manufacturing and testing components.
- Company
- KBI Biopharma, Inc.
- Product Type
- Biologics
ID · de9bf294-ca62-4148-ad63-eca729b07ab0