Berkeley Biologics LLC – FDA EIR, Sep 7, 2011

An FDA inspection of Tissue Banks International - National, located at 2597 Kerner Blvd, San Rafael, CA, was conducted from January 23 to February 17, 2012. This routine surveillance inspection focused on the company's operations as a Human Tissue Establishment, which involve the receipt, microbial testing, processing, packaging, labeling, storage, and distribution of cadaveric human tissue products. The inspection was carried out under the regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

Despite corrections made from a previous 2008 inspection, the recent assessment identified three significant observations, leading to the issuance of an FDA Form 483 and a "Voluntary Action Indicated" (VAI) classification. The primary issues included a failure to adequately validate processing methods for Fresh Skin and Cryopreserved Skin Allografts. Inspectors also discovered expired products within the distributable inventory, indicating inadequate inventory management. Furthermore, the company failed to complete the investigation of a reported customer complaint within its own established procedural timeframes.

In response, Quality Assurance Management affirmed the firm's commitment to high-quality standards and pledged to provide a written response addressing the findings. The company's response, deemed "Adequate, Requires Verification," was submitted. Management also noted plans to relocate operations to a new, larger facility within 15 months. The FDA expects the company to take appropriate voluntary corrective actions to resolve the identified deficiencies.