FDA 483 - Cantor & Barnard Ltd. - June 28, 2018

Cantor & Nissel Ltd., a Class II Medical Device Manufacturer in Brackley, Northamptonshire, United Kingdom, received a Form FDA 483 with two observations. The inspection revealed deficiencies in process validation for their water purification system and inadequate procedures for environmental monitoring. These issues indicate a lack of established controls for critical manufacturing processes and environmental conditions.