FDA EIR - ProPharma Group, LLC DBA PI ARM - July 15, 2015

An FDA inspection of ProPharma Group, LLC DBA PI ARM in Overland Park, KS, was conducted from July 13 to July 15, 2015. This initial inspection focused on the contract post-marketing surveillance company's adverse drug experience (PADE) reporting activities, including the receipt of adverse events, procedure review, and third-party contract management. The inspection was carried out under CP 7353.001A, Adverse Drug Experience Reporting Regulations-Center Initiated. ProPharma Group, LLC DBA PI ARM primarily functions as a third-party intake center for adverse events and medical information queries, forwarding them to clients. The firm explicitly does not perform pharmacovigilance activities such as severity assessment, Medwatch report development, or FDA submissions. Importantly, the inspection concluded with no findings; an FDA Form 483, Inspectional Observations, was not issued. No violations or significant issues were identified during the review of their operations, training program, adverse event/product complaint handling, or corrective/preventative actions. At the closeout meeting, management was reminded of their responsibility to adhere to the Federal Food, Drug, and Cosmetic Act, but no specific required actions were necessitated by the inspection findings.