# FDA 483 - ENDOMAGNETICS LTD - May 17, 2018

Source: https://www.globalkeysolutions.net/records/483/endomagnetics-ltd/b701020f-cb9c-4126-abc1-4f9236a61cf1

> FDA 483 for ENDOMAGNETICS LTD on May 17, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDOMAGNETICS LTD
- Inspection Date: 2018-05-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of ENDOMAGNETICS LTD, a medical device manufacturer in Cambridge, United Kingdom, identified deficiencies in their quality system. The firm failed to adequately document verification actions for corrective and preventive actions (CAPA). This indicates a lack of robust control over the effectiveness of their corrective measures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marissa-steinhagen/e7b201f4-63ce-4115-b412-714a0b8c25dc)

Company: https://www.globalkeysolutions.net/companies/endomagnetics-ltd/f5396134-da22-49f2-b16a-31c97953536b

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