Implants International Ltd.July 25, 2024

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

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Record Details

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.

Company: Implants International Ltd.
Inspection Date: July 25, 2024
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Melissa Zuppe

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ID · 3dc229cc-43b9-4def-be9e-af2d5ede8ca9