# FDA 483 - Pennine Healthcare - July 05, 2018

Source: https://www.keypedia.com/records/483/pennine-healthcare/f5bb2376-286b-4330-a1f6-a69dae80a47b

> FDA 483 for Pennine Healthcare on July 05, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pennine Healthcare
- 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 Pennine Healthcare in Cardiff, UK, from July 2-5, 2018, identified significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company's CAPA system failed to adequately evaluate non-conformities, document activities and results, and incorporate all quality data sources. This indicates a moderate severity issue regarding quality system controls for medical device manufacturing.

## 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/pennine-healthcare/7bf17a44-8e70-4f60-bb87-04585eb47c5f

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