Covidien Gets Form 483 for Complaint Procedures

FDA inspectors hit Covidien with a Form 483 for inadequate complaint evaluation and process control procedures, as well as failure to ensure appropriate design and installation of manufacturing equipment.

Following a September 2016 of the company’s Sunnyvale, Calif., facility, inspectors reported that procedures for receiving, reviewing, and evaluating complaints by a formally designated unit were not adequate. For example, a service technician filled out a Physician Feedback form without getting answers from the complainant. This resulted in several errors, including questions on the form being based on assumptions made by the service technician and not confirmed by any of the complainant’s clinical personnel; a complaint form containing incorrect information; a 14-day delay in issuing a complaint; and the complaint being closed without a determination of whether a Medical Device Reporting investigation was required.

The Form 483 also said procedures describing process controls necessary to ensure conformance to specifications were not adequately established. Covidien manufactured certain lots of product in its clean environment rooms when a Comparative Effectiveness Research certification was expired, without noting the deviation in the device history record as the company’s written procedures required. — Jeff Kinney