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483
•Cantor & Barnard Ltd.•June 28, 2018

Cantor & Barnard Ltd. – FDA 483, Jun 28, 2018

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
View Company Profile

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

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