Contract Sterilizer Cited by FDA

Isotron, a contract sterilizer of various medical devices, was cited by the FDA for changing specifications to processes via deviation or concession reports without conducting design control and validation testing, according to a warning letter.

“Deviation/concession reports cannot be used as a way to circumvent the design control process to avoid performing validations on changed processes and specifications,” the warning letter said. “This is not an appropriate use for the nonconformance processing system.”

The letter cited Isotron’s facility in Tullamore, Ireland, which has a microbiological laboratory and uses an ethylene oxide sterilization platform. Isotron is a subsidiary of Synergy Healthcare and has multiple sites throughout Europe and Asia.

The facility also was cited for not adequately investigating root causes for nonconformities. Investigations were not closed out in a timely manner because target dates for completion were repeatedly changed. “In this way, your firm is allowing a failure investigation to continue endlessly without justification,” the warning letter said.

The letter can be accessed at www.fda.gov/foi/warning_letters/s6679c.pdf.