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

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.