FDA EIR - OSO Biopharmaceuticals Manufacturing LLC - December 07, 2016

A comprehensive FDA surveillance inspection of OSO BioPharmaceuticals Manufacturing, LLC (OsoBio), a sterile drug and biopharmaceutical manufacturer in Albuquerque, NM, took place from November 28 to December 7, 2016. This inspection adhered to FDA Compliance Programs for sterile drug, DPI/biotech, and animal drug manufacturing, evaluating adherence to Current Good Manufacturing Practices (cGMP) across all operational systems.

Upon conclusion, OsoBio received a two-item FDA Form 483, Inspectional Observations. The main violations included a failure to establish scientifically sound and appropriate laboratory specifications, standards, and test procedures, specifically regarding the visual identification of particles without scientific validation or investigation into potential misidentification. Additionally, backup data, such as validated spreadsheets, was not consistently maintained to ensure it was exact, complete, and secure from alteration, erasure, or loss, with original print-outs often not retained.

Mr. David M. Lee, OsoBio's General Manager, acknowledged these findings and committed to implementing the necessary corrective actions. The company is required to submit a written response detailing their actions within 15 business days.