Design Control, CAPA Violations Bring Warning for Transonic
Transonic Systems, a maker of devices to measure cardiac output, has fielded an FDA warning letter for design control and other quality system violations.
According to the June 19 letter, the Ithaca, N.Y., company may have manufactured or released some of its COstatus units before the final gate of its “phase and gate approval system.” Gate 4 approval typically ends the design phase and certifies the product is ready to be manufactured and marketed, the letter adds.
Another citation states the design history file for the COstatus monitor lacks documentation of what was reviewed during design reviews. And design verification and validation activities failed to show the COstatus system conforms to intended uses, such as allowing easy movement of the system from one patient to another.
Acceptance criteria were not established prior to the verification and validation activities, the warning letter notes.
“Your validation reports should have had a documented conclusion of whether or not established acceptance criteria were achieved,” the letter adds. Transonic’s post-inspection response did not explain this violation, or how the company will correct it.
Another documentation shortfall involved Transonic’s corrective and preventive action activities. One CAPA failed to document all failure modes associated with leaking COstatus AV Loops, such as “blood leaked into cassette” or “the venous part of tube was leaking,” the letter says.
Some complaint records for the AV loops were missing complete documentation of investigation activities, including the results, or documentation on whether corrective action was required.
Meanwhile, Transonic has not established procedures for handling Engineering Project Requests for manufacturing its AV Loops.
“It is unclear as to whether products manufactured under EPRs need to conform to specifications and can be released for distribution. In addition, forms utilized for EPRs lack traceability for which components and accessories are manufactured under EPRs,” the letter says.
The company also failed to document investigation activities that led to another CAPA for COstatus monitor glitches.
When a medical devicemaker receives a Form 483 or a warning letter, it could be because someone doesn’t do his or her job properly somewhere in the production process. At FDAnews’ Medical Device Quality & Compliance Institute 2013 Quality Systems and Design Control Training you’ll learn how to make sure that every member of your team is functioning at 100 percent efficiency. Reserve your spot at this conference today.