RoTech Medical Unit Stops Making Oxygen After FDA Warning
By ANITA WOMACK Dow Jones Newswires
ROCKVILLE, Md. -- A unit of RoTech Medical Corp. (ROTC) stopped making medical oxygen after receiving a warning letter from the Food and Drug Administration about its lack of quality control.
The warning letter, dated July 15, was issued following an inspection of Respiratory Home Care Consultants in West Middlesex, Pa., in June.
Scott Novell, corporate counsel for RoTech, says officials decided to cease operations as a manufacturer around July 20 and will only distribute medical oxygen.
RoTech notified the FDA Aug. 13 of their decision.
The West Middlesex plant was a transfilling facility where the company took oxygen in its liquid form and transfilled it into a gaseous form from large containers to smaller ones. RoTech will now buy the smaller containers of oxygen and distribute them to customers, officials said.
The June inspection was conducted as a follow up to two prior inspections conducted in August 1996 and November 1996. "After each inspection, corporate management has proposed corrective actions to the specific items identified by the FDA investigator," the warning letter states. "This non-systemic approach to quality management, however, falls short of FDA expectations. The lack of adequate controls in processing of medical gases for respiratory care has the potential to cause serious injury to patients, including death."
The warning letter cited RoTech for failing to assay the incoming liquid oxygen for identity and strength prior to filling liquid home units, failing to establish a system of documentation to reliably correlate supplier lot numbers with filling and receiving records, and failing to establish procedures for quality control. |
