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

Source: https://www.globalkeysolutions.net/records/483/cantor-barnard-ltd/94244e2f-1af4-472d-b19c-a5f3ab0f18d8

> FDA 483 for Cantor & Barnard Ltd. on June 28, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cantor & Barnard Ltd.
- Inspection Date: 2018-06-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.globalkeysolutions.net/companies/cantor-barnard-ltd/67f02597-561b-443e-b9f5-ade573e6ef75

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd