GE Unit Cited for Training, Quality System Violations

An FDA inspection found that GE Ionics had no documentation to show employees received required training.

According to a recent warning letter, the firm’s onsite manager said there were no written design control procedures or records to document the design development process or design changes in the mixed-bed deionization and carbon tanks. The company manufactures water purification tanks to provide water for hemodialysis treatment.

The onsite manager said that in 2003, the firm switched the type of resins it used for manufacturing the tanks, but this verbal design change was not documented, according to the letter.

The FDA said it is concerned that, following the acquisition of Ionics Ahlfinger Water by GE, the company may not have adequately maintained its records to prove its water purification tanks are exempt from 510(k) premarket notification requirements as they use current resin and carbon materials.

The warning letter can be seen at www.fda.gov/foi/warning_letters/s6554c.pdf.