Albemarle US, Inc. – FDA EIR, Jan 25, 2019

An FDA inspection of Albemarle US, Inc., an active pharmaceutical ingredient manufacturer in Kings Mountain, NC, was conducted from January 22-25, 2019. The inspection assessed compliance with Compliance Program 7356.002F and ICH Q7 guidance for Active Pharmaceutical Ingredients. Key observations spanned several operational areas. Within the Quality System, issues included missing lot information in annual product reviews for non-pharmaceutical grade products, the lack of a site-specific recall procedure with periodic testing, and inconsistent documentation for extended deviation investigations. Facilities and Equipment concerns highlighted the use of Merv 8 rated air filters in the packaging room, deemed inadequate for pharmaceutical environments. The Production System lacked evaluations of lot quality when varying batches were combined and a formal hold-time study for wet cake storage. Laboratory Controls exhibited an absence of a comprehensive log for sample traceability and insufficient detail in test solution preparation records. Lastly, the Packaging and Labeling System for HP grade Lithium Carbonate did not include a statement preventing its use in pharmaceutical applications, posing a risk of diversion. Albemarle US, Inc. management committed to implementing corrective actions for all verbal observations, and the Agency will conduct further review to determine the final compliance status.