FDA EIR - West Services and Solutions, LLC - January 22, 2016

An FDA routine current Good Manufacturing Practice (cGMP) inspection of West Pharmaceutical Services - West Analytical Services, a contract testing laboratory located in Exton, PA, was conducted from January 20-22, 2016. This surveillance inspection, performed in accordance with CP 7356.002 Drug Manufacturing Inspections, aimed to assess the company's compliance as a facility specializing in extractable and leachable testing for container closure systems, along with other compendial and analytical services. The previous inspection, ending in March 2012, was classified "No Action Indicated" (NAI), with no FDA 483 issued. The current inspection provided extensive coverage of the firm's Quality, Laboratory, Materials, Facilities and Equipment, and general cGMP systems. Records reviewed included written procedures, the purified water system, validation of analytical and compendial methods, complaint and deviation investigations, and stability programs. Despite a detailed examination of various operational aspects and a facility tour, the inspection revealed no objectionable conditions. Consequently, no Form FDA 483 Inspectional Observations were issued at the closeout meeting. This outcome indicates the company's operations were found to be in compliance with applicable regulatory requirements, and no specific actions were mandated by the FDA following this inspection.