FDA EIR - Adare Pharmaceuticals, Inc. - July 11, 2018

An FDA Postmarketing Adverse Drug Experience (PADE) surveillance inspection was conducted at Adare Pharmaceuticals Inc. in Vandalia, OH, from July 9-11, 2018. The inspection, performed under Compliance Program 7353.001, focused on the company's PADE reporting processes, particularly given that pharmacovigilance activities were outsourced to third-party organizations.

During the inspection, no Form FDA-483 (Inspectional Observations) was issued, indicating an overall compliant status. However, a specific issue was noted regarding Standard Operating Procedure (SOP)-00713, "Management of Periodic Safety Reports (PSUR/PADER)," which had been in use since 2015 but lacked formal approval by upper management at the site. This procedure details responsibilities for developing and submitting safety reports to regulatory authorities.

In response to this observation, Adare Pharmaceuticals Inc. promptly addressed the issue. By the close of the inspection on July 10, 2018, the firm ensured the appropriate personnel at the global level had officially approved SOP-00713. This voluntary correction resolved the identified administrative discrepancy, leading to no significant observations or formal required actions by the FDA. The inspection concluded without any refusals or samples collected.