LANXESS Corporation – FDA EIR, Dec 17, 2009

An FDA inspection was conducted at Emerald Kalama Chemical, LLC, located in Kalama, WA, from December 14 to December 17, 2009. The inspection focused on the company's corrective actions, laboratory methods, product labels, and production records. The regulatory framework for this inspection is based on FDA requirements, primarily Good Manufacturing Practices (GMP), as evidenced by the issuance of a three-item Form FDA 483, Inspectional Observations. The main issues identified during the inspection included a lack of complete evaluation for micron sock filters used in product transfer lines. Secondly, the facility failed to ensure laboratory equipment, specifically a refractometer, met calibration specifications before testing finished drug products, and accepted measured values without proper written justification for this deviation. Finally, the company did not conduct or adequately document a systematic review of all production and validation data prior to accepting and releasing finished drug products for distribution. In response to these observations, the firm's management committed to submitting a written response addressing each Form FDA 483 observation to the Seattle District Office Compliance Branch within 15 business days. No samples were collected, and no refusals were encountered during the inspection. The firm's FDA Drug Establishment Registration was current.