Cantor & Barnard Ltd.June 28, 2018

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

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Record Details

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.

Company: Cantor & Barnard Ltd.
Inspection Date: June 28, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Monica C. Burgos Garcia

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ID · 94244e2f-1af4-472d-b19c-a5f3ab0f18d8