FDA EIR - Allergan Sales, LLC - June 06, 2019

A routine FDA sponsor inspection of Allergan Sales, LLC, located in Madison, NJ, was conducted from May 29, 2019, to June 6, 2019. This inspection, requested by the Center for Drug Evaluation and Research (CDER), aimed to assess the firm's compliance with applicable regulations, specifically under the Sponsor, Contract Research Organizations and Monitors Compliance Program Guidance Manual. This marked Allergan's initial sponsor inspection at this particular site. It is noteworthy that a previous Risk Evaluation Mitigation Strategies (REMS) inspection in April 2017 had resulted in a Form FDA 483. This prior inspection cited two observations: the application holder failed to dispense the Medication Guide as required by its approved REMS, and did not maintain a Support & Call Center or a REMS Program website according to its approved REMS Implementation System. However, a closeout meeting in June 2017 confirmed that those prior issues were addressed. During the most recent May-June 2019 inspection, the investigator reviewed various records, including vendor agreements, clinical monitoring plans, standard operating procedures (SOPs), training records, and monitoring visit reports for two specific clinical protocols. This inspection did not identify any new deficiencies or issues. Consequently, no Form FDA 483 (Notice of Inspectional Observations) was issued at the conclusion of this inspection, indicating that Allergan Sales, LLC was found to be in compliance with the reviewed regulatory requirements during this period.