# FDA 483 - Fibrocell Technologies, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/fibrocell-technologies-inc/c27fedf9-face-4db8-a960-860a0749be3b

> FDA 483 for Fibrocell Technologies, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fibrocell Technologies, Inc.
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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Company: https://www.keypedia.com/companies/fibrocell-technologies-inc/35acc167-104a-44ea-981b-3f5a842edc06

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1