# FDA 483 - Tristel Solutions Limited - February 13, 2025

Source: https://www.keypedia.com/records/483/tristel-solutions-limited/ffca37ac-f551-4675-80e8-7ec240c08e94

> FDA 483 for Tristel Solutions Limited on February 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tristel Solutions Limited
- Inspection Date: 2025-02-13
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Tristel Solutions Limited, a medical device manufacturer in Snailwell, United Kingdom, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, insufficient control over non-conforming products, and incomplete documentation of design validation results. These issues indicate a need for improved quality management practices at the facility.

## Related Documents

- [483 - 2025-02-13](https://www.keypedia.com/records/483/tristel-solutions-limited/db32b0f7-f20a-4546-b75f-6f70ab35f9f4)

## Related Officers

- [Melanie W. Pishnery](https://www.keypedia.com/people/melanie-w-pishnery/ff4846b0-ffe1-4df0-9116-4bb238866b3a)

Company: https://www.keypedia.com/companies/tristel-solutions-limited/dcbb575e-8c80-47bf-9837-49e99b216129

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4