# FDA 483 - Eakin Surgical Ltd - July 05, 2018

Source: https://www.keypedia.com/records/483/eakin-surgical-ltd/0c436433-2431-438e-b420-0f9c0c8dad1b

> FDA 483 for Eakin Surgical Ltd on July 05, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eakin Surgical Ltd
- Inspection Date: 2018-07-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Pelican Feminine Healthcare DBA Single Use Surgical in Cardiff, UK, revealed a significant deficiency in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions (CAPA). This indicates a moderate severity issue related to quality management system controls.

## Related Officers

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

Company: https://www.keypedia.com/companies/eakin-surgical-ltd/bfc654ce-d69c-4254-9059-415a93da5bdc

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