MedOne Handed Form 483 on Complaint Records
MedOne Surgical, a Sarasota, Fla., devicemaker, received an FDA Form 483 for failures related to complaint records, in-process acceptance and other procedures.
The company's records for two complaints said that a device did not malfunction, although MedOne's records did not adequately demonstrate that this was the case, according to the form.
MedOne also did not define, document and implement acceptance criteria for a pull test as part of in-process and final acceptance activities for its FlexTip Cannula. The firm’s records did not list the actual results of acceptance activities and instead listed the date they were performed and the initials of the employee conducting the activities.
The four-observation form also rapped the company for failing to demonstrate in a device history file that a product was manufactured in accordance with the device master record. The FDA also notes that MedOne had not adequately implemented its in-process testing procedure, which requires it to repeat a quality assurance check at the halfway point for certain lots. Some of the company's product records show the QA check was conducted following production.
For a procedure on assembly and bonding of tubing into cannulas, the company's final acceptance activities did not include performing destructive pull testing, as described in the assembly procedure, the form says.
The company did not respond to a request for comment by press time. The form can be found at www.fdanews.com/02-01-15-MedOne.pdf.