FDA EIR - Lonza Bend Inc - June 03, 2016

An FDA Post-Approval audit of Bend Research Inc., a contract manufacturing organization, was conducted from May 16 to June 3, 2016. The inspection, carried out under Compliance Program CP7356.843, covered the company's Production facility, Control Testing Laboratory (FEI: 1000656789), and Supply Chain Warehouse. This current inspection identified significant deficiencies, particularly within the Control Testing Laboratory and the broader Quality Unit. Key violations included the Quality Unit's failure to adequately oversee operations, evidenced by the use of unvalidated and uncontrolled Excel spreadsheets for calculating analytical release test results. Furthermore, the Quality Control Unit lacked sufficient controls over security access for its computerized systems, and sample log books for inventory transactions were not properly verified, signed, and dated. The Quality Unit also failed to ensure all potentially affected batches were identified during investigations. These observations collectively highlighted a systemic issue with data integrity and the overall effectiveness of the firm's quality management and training programs. As a result, Form FDA 483 Inspectional Observations were issued to all three facilities. Bend Research Inc. management committed to submitting a written response to the FDA within fifteen business days detailing their corrective actions.