FDA 483 - Lonza Bend Inc. - August 05, 2018

During an inspection conducted from July 25 to August 5, 2022, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Bend Research, Inc., a contract manufacturer located in Bend, Oregon. The observations primarily highlighted significant deficiencies within the company's quality systems regarding discrepancy investigations.

Specifically, the FDA noted that investigations into unexplained discrepancies, such as a large powder accumulation during enzalutamide spray drying, did not adequately extend to all potentially affected batches of the same drug product. This oversight could lead to the distribution of compromised products. Furthermore, several investigations into deviations and complaints, including specific examples like CP-0040 and CP-0042, frequently concluded with "no definitive root cause" or attributed issues vaguely to "human error" without sufficient scientific justification. Consequently, these investigations often lacked clear corrective actions.

The FDA emphasized that thorough root cause analysis is critical for identifying and resolving product quality issues, indicating a failure to adhere to expected Good Manufacturing Practices (GMP) for quality control. Bend Research, Inc. is now expected to provide a comprehensive response detailing corrective and preventive actions to address these serious observations and ensure the integrity of its manufacturing processes and products.