CryoSurgery Inc. landed a Form 493 for poorly documented acceptance activities and inadequate procedures for ensuring the quality of received products.
During an inspection of the refrigerated gases company’s Nashville, Tenn. facility, the FDA found that acceptance activities were not adequately documented and maintained as part of device history records for cryotherapy canisters following their distribution. Specifically, checks of boxes of the canisters were documented on the outside of each box. However, when the boxes were discarded, the acceptance activity record was not maintained.
Inspectors also reported that CryoSurgery failed to establish procedures to ensure that all purchased or otherwise received products and services conformed to specified requirements. In particular, the company did not establish requirements for evaluating and controlling suppliers of services and consultants, and a vender providing calibration services was not evaluated based on its ability to meet requirements.
Devicemakers must be ready to comply with the new ISO 9001:2015 standards starting in September 2017 — for firms seeking first-time certification — and September 2018 for firms with current certification. ISO 9001:2015 includes a timetable for transitioning to the new certification. Don’t get left behind in securing your certification.