LANXESS Corporation – FDA EIR, Aug 2, 2013

The Food and Drug Administration conducted a comprehensive surveillance inspection of Emerald Kalama Chemicals, LLC, located in Kalama, WA, from July 29 to August 2, 2013. This inspection was performed under Compliance Program 7356.002F, focusing on the firm's Active Pharmaceutical Ingredient (API) processes, including products like Benzyl Alcohol. The scope of the inspection covered a review of Standard Operating Procedures, change control, and deviations. Inspectors also verified that corrections had been made in response to observations from a previous inspection in December 2009, which had resulted in a Voluntary Action Indicated (VAI) classification and an FDA Form 483. During the 2013 inspection, no new inspectional observations (FDA Form 483) were issued, and no samples were collected, recalls conducted, or refusals encountered. Consequently, the FDA classified this inspection as "No Action Indicated" (NAI), meaning no significant regulatory violations were identified and no further actions were required from the company by the agency at that time.