Light Age received a Form 483 for multiple deficiencies observed in an inspection of its Somerset, N.J., facility including the lack of a device master record and failing to launch corrective and preventive action (CAPA) procedures.

The SEIU-United Healthcare Workers West union in California has petitioned the FDA to issue corrective recalls for Fresenius 2008K2, 2008T, and 2008T BlueStar hemodialysis machines to protect patients from high ultrafiltration rates and assure accurate conductivity — concentration of dialysis fluid.

Ceragroup Industries (CGI), a Florida manufacturer and distributer of dental porcelain products, recently received a Form 483 citing repeat problems with incomplete corrective and preventive action (CAPA) procedures and equipment lacking proper calibration.