Kelyniam Called Out for Environmental Controls

The FDA cited Collinsville, Connecticut-based devicemaker Kelyniam for lacking environmental controls, including having manufacturing operations near an area where cleaning was being conducted.

The agency found that the company manufactured cranial and craniofacial implants close to the area it cleaned the devices. The investigator found visible particulates in both areas during the inspection.

For example, while a cranial implant was being made, an employee placed a bottle of isopropyl alcohol and tools on an implant washing tray, then placed a cleaned implant directly on the tray    while blowing out manufacturing particulates.