FDA EIR - Almac Clinical Services, LLC - August 01, 2018

An FDA inspection of Almac Clinical Services, LLC, located in Souderton, PA, was conducted from July 30 to August 1, 2018. This initial, comprehensive inspection focused on the company's role as the U.S. Agent for a pharmaceutical manufacturer, specifically assessing compliance with the Risk Evaluation and Mitigation Strategies (REMS) program for a particular drug product. The inspection was carried out under the guidance of the REMS Compliance Team and Compliance Program Guidance Manual 7353.001c, which pertains to REMS reporting inspections. The review covered the identification of contractors involved in the REMS program, their contracts, and scopes of work. It also examined the drug's REMS Elements to Assure Safe Use and the overall implementation system. This included scrutinizing healthcare facility certification, recertification processes, training documentation, and adherence to requirements for managing acute bronchospasm. Wholesaler and distributor enrollment, training, and distribution recordkeeping practices were also verified. Notably, at the conclusion of the three-day inspection, no Form FDA 483, 'Inspectional Observations,' was issued, nor were any verbal observations made by the investigator. This indicates that Almac Clinical Services, LLC demonstrated satisfactory adherence to the regulatory requirements pertaining to the REMS program evaluated during this inspection. No specific corrective actions were required by the FDA as a direct result of these findings.