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

Source: https://www.globalkeysolutions.net/records/483/rua-medical-prestwick/caff9118-50f6-48b7-971e-f74f2b15171c

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

---

## Details

- Record Type: 483
- Company Name: RUA Medical (Prestwick)
- Inspection Date: 2018-10-18
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Summary: During an inspection conducted from October 15-18, 2018, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to RUA Medical (Prestwick), located in the United Kingdom. This document outlines observations made by an FDA investigator concerning the company's quality system. The primary issue identified was that procedures to control environmental conditions within the manufacturing facility were not adequately established. Specifically, the firm's clean room monitoring procedure did not sufficiently address non-viable airborne particle warning levels, which is critical for maintaining product quality and safety. The FDA Form 483 serves as a notice of inspectional observations and indicates potential areas where the firm may not be fully compliant with regulatory requirements for medical device manufacturers. RUA Medical is responsible for conducting internal self-audits to identify and correct any and all violations of quality system requirements. The company is expected to address these observations by implementing appropriate corrective actions to ensure its processes meet required standards.

## Related Documents

- [483 - 2018-10-18](https://www.globalkeysolutions.net/records/483/rua-medical-prestwick/082c69f8-3bad-466c-9b55-b9ed2a3f5b2a)

## Related Officers

- [Chief Executive Officer](https://www.globalkeysolutions.net/people/dr-caroline-stretton/600d755e-4641-4a20-8152-995904b74ada)
- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

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

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7