483
Fibrocell Technologies, Inc.Fibrocell Technologies, Inc. – FDA 483
Record Details
Fibrocell Technologies, Inc. in Exton, PA, was inspected regarding its autologous cellular therapy product, LaViv. The inspection revealed significant issues across laboratory controls, adverse event reporting, and stability program management. Specifically, the firm's OOS procedure allowed retesting before investigation, adverse events were not timely reported, and changes to the stability program lacked proper change control.
- Company
- Fibrocell Technologies, Inc.
- Product type
- biologics
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ID · c27fedf9-face-4db8-a960-860a0749be3b
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