FDA EIR - Ajinomoto Althea, Inc. - June 11, 2013

An FDA inspection of Ajinomoto Althea Inc., a contract manufacturer of biological and clinical drug products in San Diego, CA, was conducted from May 30 to June 11, 2013. This routine Good Manufacturing Practices (GMP) inspection covered quality, production, facilities and equipment, and materials systems.

The inspection resulted in a Form FDA-483, detailing several significant observations. Key issues included deficiencies in the final drug product inspection system: rejection rate limits were applied generically across all products and lines, lacking product-specific data, and individual defect rates for issues like foreign matter or cracked vials were not established. Foreign matter, identified in a product batch, was not adequately investigated or identified, and an uncontrolled form was used for defect classification. Furthermore, the firm's investigation into vial residue from a manufacturer's treatment was deemed inadequate, with no assurance of residue removal post-wash and an unjustified reclassification of this residue from a critical defect to acceptable. Aseptic connection points critical to the fill-finish process were omitted from sterilization studies. The facility also failed to consistently monitor clean steam points as required by their standard operating procedures, and several environmental monitoring excursions and deviations were not investigated or closed in a timely manner.

Management, represented by President & CEO Rick B. Hancock, acknowledged the observations, promised corrective actions, and committed to submitting a written response to the FDA within 15 days. These actions are crucial for ensuring compliance with regulatory standards for drug product manufacturing.