FDA 483 - Roberts Oxygen Company Inc - December 12, 2019

An FDA inspection of Roberts Oxygen Company Inc, a medical gas manufacturer in Gaithersburg, MD, revealed deficiencies in laboratory records. Specifically, the firm's Gas Chromatography analyses for medical gases like Helium USP, Nitrous Oxide USP, and Nitrogen NF were inadequate, failing to capture potential impurities and lacking the use of blanks or specific test methods. These issues indicate a failure to assure compliance with established specifications and standards.