FDA EIR - Olon Ricerca Bioscience LLC - January 22, 2019

Olon Ricerca Bioscience LLC underwent a routine Good Manufacturing Practice (GMP) inspection by the FDA from January 16-22, 2019. The inspection, conducted under the Active Pharmaceutical Ingredient (API) Process Inspection regulatory framework (CP 7356.002F), focused on the company's operations as an API manufacturer and control testing laboratory in Concord, OH. The facility was not manufacturing API product during the inspection but confirmed corrections to prior minor deficiencies noted in previous GMP inspections. The inspection covered Quality, Production, Materials, and Laboratory Systems. At the conclusion of the inspection, no significant observations were noted, and no FDA-483, Inspectional Observations, was issued. However, the FDA verbally discussed with management one key area for improvement. The firm was advised to consistently meet established timeframes for closing out deviations, change controls, investigations, and laboratory investigation reports. Additionally, there was a discussion about the need for enhanced senior management oversight to ensure that change controls are effectively closed out and that appropriate effectiveness checks are conducted over time. Management was cooperative, and the firm maintains current FDA registration.