483
Bora Pharmaceuticals Injectables IncFDA 483 - Bora Pharmaceuticals Injectables Inc
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Record Details
Cangene BioPharma in Baltimore, MD, received a Form 483 following a Pre-Approval Inspection. The inspection revealed significant deficiencies in process validation, including failed batches and inadequate testing. Additionally, the firm lacked sufficient controls to prevent cross-contamination and demonstrated insufficient cleaning verification for product contact equipment.
- Product Type
- Biologics
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ID · 356911f2-117b-44f4-a196-a5fadcd6a699