Poly Pharmaceuticals, Inc – FDA EIR, Jan 24, 2018

An FDA inspection of Poly Pharmaceuticals, Inc., an own-label distributor based in Owens Cross Roads, AL, was conducted from January 22-24, 2018. The inspection focused specifically on the company's compliance with post-marketing adverse drug event reporting regulations, particularly concerning their distributed prescription drug, Ibudone (hydrocodone bitartrate plus ibuprofen), and various over-the-counter products. The inspection resulted in the issuance of a Form FDA 483, citing a significant observation: the company had not developed written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences. This directly violated regulatory requirements outlined in 21 CFR 314.80(b). Additionally, the firm lacked an established account with the FDA's safety reporting portal necessary for submitting adverse event reports. Management's claim of no adverse events for Ibudone over six years could not be verified due to the absence of these procedures. In response to these findings, Poly Pharmaceuticals' management promptly initiated voluntary corrective actions during the inspection. These included drafting an initial Standard Operating Procedure (SOP) for adverse drug experience collection and handling, though the initial draft required further refinement for clarity and accuracy regarding reporting responsibilities. Furthermore, the company began the process of registering for an account with the FDA's safety reporting portal. The firm committed to submitting a formal response to the FDA 483 within 15 business days, outlining their comprehensive plan to address the identified deficiencies and ensure compliance with adverse event reporting requirements.