Lights Medical successfully passed the FDA’s on-site inspection, establishing a solid defense for quality control.
Release time:
2024-11-12
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Recently, JinYao Puguang successfully passed the FDA’s on-site inspection after eight days and nights of intensive effort. This marks the company’s fourth time obtaining this clearance certification—following its previous successes in 2013, 2015, and 2018—and comes six years after its last such achievement.
Recently, Lights Medical successfully passed the FDA’s on-site inspection after eight days and nights of intensive effort. This marks the company’s fourth time obtaining this clearance certification—following its previous successes in 2013, 2015, and 2018—and comes six years after its last such achievement.

The FDA’s unannounced inspections are renowned for their suddenness and stringent standards, and are regarded as a “surprise comprehensive test” of a company’s production quality and management system. This round of unannounced inspection will be officially conducted from November 4 to November 8, 2024. From the moment the company receives notification to the arrival of inspectors at the facility, only four days are allotted for preparation, placing extremely high demands on the company’s emergency response capabilities and day-to-day management levels.
On the evening of October 30, after receiving the inspection notice, the company immediately activated its emergency response plan for the inspection and swiftly established a special task force to coordinate and deploy resources. All departments sprang into action, working in close collaboration. In the production workshop, staff strictly adhered to the Standard Operating Procedures (SOP), meticulously controlling every stage of the production process. The laboratory, with its rigorous and professional attitude, repeatedly verified all data to ensure accuracy and precision. Meanwhile, the logistics support team made every effort to coordinate the supply of materials and maintain equipment operations, providing a solid and reliable backing. All employees united their efforts and remained on duty day and night, fully committed to the inspection preparation work with a strong sense of responsibility and solid professional competence.
During the review period, FDA officials conducted meticulous inspections and thorough inquiries at every stage. Company employees responded calmly and confidently, earning the approval of the reviewers thanks to their solid professional expertise, comprehensive documentation, and standardized production processes. When the news of passing the inspection was announced, everyone shared in the joy of victory—every bit of previous fatigue was transformed into renewed motivation and energy.
This successful clearance not only highlights the company’s robust quality control system but also strengthens team cohesion and unity. Moving forward, Lights Medical will continue to uphold its spirit of hard work, strictly adhere to international standards, and build an even stronger quality defense through even more rigorous requirements, thereby laying a solid foundation for the company’s deepening engagement in the global market.

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