FDA 483 - Curia New Mexico, LLC - December 07, 2016

Oso BioPharmaceuticals Manufacturing, LLC, a drug manufacturer in Albuquerque, NM, received two observations during an FDA inspection. The observations highlight deficiencies in laboratory controls, specifically regarding the lack of appropriate visual standards for particle identification in drug product vials, and issues with data integrity concerning the retention of true copies of analytical records. These findings indicate areas where the firm's practices do not fully comply with regulatory requirements.