# FDA 483 - RUA Medical (Prestwick) - October 18, 2018

Source: https://www.keypedia.com/records/483/rua-medical-prestwick/082c69f8-3bad-466c-9b55-b9ed2a3f5b2a

> FDA 483 for RUA Medical (Prestwick) on October 18, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RUA Medical (Prestwick)
- Inspection Date: 2018-10-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of NUA Medical (Prestwick) in Prestwick, United Kingdom, identified a significant deficiency in their manufacturing operations. The firm failed to adequately establish procedures for controlling environmental conditions, specifically regarding the monitoring of non-viable airborne particle warning levels in their clean room.

## Related Documents

- [483 - 2018-10-18](https://www.keypedia.com/records/483/rua-medical-prestwick/caff9118-50f6-48b7-971e-f74f2b15171c)

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/rua-medical-prestwick/eb0ec264-3466-4795-9522-7a3c619b277b

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