FDA EIR - Arbor Pharmaceuticals Inc. - January 28, 2016

An FDA inspection of Arbor Pharmaceuticals Llc's corporate office in Atlanta, GA, was conducted from January 26-28, 2016. This CDER-initiated inspection focused on adverse drug experience (ADE) reporting compliance under Post Marketing Adverse Drug Experience Reporting Regulations (CP7353.001). The inspection identified several significant issues. Primarily, twenty-three serious and unexpected ADE reports were not submitted to the FDA within the required 15 calendar days. These delays were attributed to technical issues with fax machines (16 reports), miscategorization by a third-party service provider (5 reports), and an employee training issue (1 report). Arbor Pharmaceuticals initiated Corrective Action/Preventive Action (CAPA) reports to address these deficiencies, including CAPA #2016-019 for the overall ADE reporting issues. Furthermore, the inspection noted a lack of cGMP training for some management staff and two late Field Alert Reports for Nymalize (3 months late) and Iso-sorbide Nitrate (5 days late). While no FDA Form 483 was issued, management was reminded of the late reports. The firm demonstrated having procedures for ADE handling and stated that all electronic reports filed since September 8, 2015, have been timely. Management acknowledged the deficiencies and initiated cGMP training during the inspection, indicating a commitment to resolve the identified issues.