FDA EIR - LANXESS Corporation - January 15, 2016

Emerald Kalama Chemicals, LLC underwent an FDA inspection from January 11-15, 2016, at its Kalama, WA facility, focusing on Active Pharmaceutical Ingredient (API) Benzyl Alcohol-NF manufacturing. The inspection, conducted under the API Process Inspection framework, identified three significant issues. First, the company demonstrated a lack of appropriate controls over computer and related systems, specifically Gas Chromatographs and associated software used for API analysis. This included missing user log books, inadequate password protection and access controls, unmaintained audit trails, and the absence of mechanisms to prevent unauthorized data deletion or modification. Furthermore, analytical data was stored locally without server backup, off-site storage, or a defined backup frequency. Second, the firm failed to adequately qualify suppliers for critical production gases like Nitrogen and Oxygen, which were not tested upon receipt, and proper Certificates of Analysis were not obtained. The supplier itself had not been formally qualified. Third, the written complaint handling procedures were deficient, lacking provisions for reviewing and reporting serious, unexpected, or potentially life-threatening situations to relevant authorities, as outlined by ICH Q7 guidelines. In response, company management committed to implementing corrective actions, including establishing user logs, implementing password-protected access with defined roles for analytical software, developing SOPs for audit trail management and data backup, qualifying the gas supplier, and revising complaint handling procedures to include adverse event reporting. A written response detailing these actions was promised to the FDA within fifteen business days.