# FDA 483 - Implants International Ltd. - July 25, 2024

Source: https://www.keypedia.com/records/483/implants-international-ltd/3dc229cc-43b9-4def-be9e-af2d5ede8ca9

> FDA 483 for Implants International Ltd. on July 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Implants International Ltd.
- Inspection Date: 2024-07-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Implants International Ltd. in Thornaby-on-Tees, UK, received a Form 483 from the FDA with four observations during an inspection from July 22-25, 2024. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, complaint handling, and medical device reporting. Additionally, the firm failed to maintain required records in an accessible manner.

## Related Documents

- [483 - 2023-12-18](https://www.keypedia.com/records/483/implants-international-ltd/8a90e0b0-648b-4bd0-b0e3-ff1736df1716)

## Related Officers

- [Melissa Zuppe](https://www.keypedia.com/people/melissa-zuppe/e34e3943-0e3c-4a24-983d-6ac8aa2cc906)

Company: https://www.keypedia.com/companies/implants-international-ltd/4e54b62c-8186-4d16-ab02-4b42d2e576e4

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