Good News! Enokon Successfully Passes US FDA cGMP On-site Inspection!
Warm congratulations to Henan Enokon Medical Instrument Co., Ltd. on passing the US FDA on-site inspection!
On March 24, 2026, Henan Enokon Medical Instrument Co., Ltd. (hereinafter referred to as "Enokon") reached a milestone – the company received the official letter and Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA). The report confirmed that Enokon's quality management system is fully compliant with the FDA's current Good Manufacturing Practice (cGMP) requirements, marking the successful passing of this on-site inspection!
As the world's most authoritative regulatory body in the fields of food, pharmaceuticals, medical devices and more, the FDA is renowned for its rigorous, thorough and comprehensive inspections, and stands as a global benchmark for industry compliance and quality.
From January 20 to 23, 2026, Enokon underwent a 4-day on-site inspection by the FDA. Conducted in accordance with FDA standard procedures, the inspection covered core aspects including the quality management system, production process control, data integrity, material management, laboratory practices, and personnel qualifications. Through document review, on-site patrols, personnel interviews and other methods, the inspectors conducted a full-process, all-round and thorough verification of the company's operations, fully validating our solid foundation in compliance management and quality control.
From preparation for the inspection to the actual assessment, we have always set the goal of "zero defects" and adhered to the core philosophy of "quality first, compliance-based". We fully aligned our practices with the FDA cGMP (current Good Manufacturing Practice) and relevant 21 CFR regulations. All departments collaborated closely to sort out and improve the complete set of quality management documents, refine the operating specifications for all production links, strengthen compliance training for personnel, and conduct self-inspections and optimizations on key links such as production facilities, equipment calibration and material traceability. With our persistent efforts day in and day out, we have built a solid quality defense line, and ultimately responded to this international "assessment" with poise, earning recognition from the FDA inspectors.
The successful passing of the FDA inspection is not only the highest recognition of our long-term compliance management and quality control work, but also indicates that the company has established a standardized quality management system that complies with the FDA cGMP, marking that our quality management system has reached the international level.
Looking back on our development journey, every recognition is inseparable from the joint efforts of all employees, the pursuit of perfection in every detail, and above all, our adherence to the original aspiration of "great medical professionalism, altruism as the foundation". We have always firmly believed that quality is the lifeline of an enterprise and compliance is the foundation of its existence. The passing of the FDA inspection is not an end, but a new starting point.
In the future, the company will always adhere to the guidance of international standards, continue to build a distinctive production base with high quality, high standards, compliance and legality, and strive to become a global pharmaceutical manufacturing enterprise. At the same time, taking this as a springboard, we will actively expand more international markets, bring products meeting the world's highest standards to the globe, convey the strength of Chinese manufacturing, provide safer and more reliable products and services for global consumers, and live up to every trust and expectation!
About Enokon
Henan Enokon Medical Instrument Co., Ltd. is located at No. 2 Weiba Road, New Industrial City, Kangcun Town, Huojia County, Xinxiang City, Henan Province. We serve customers in many countries around the world, with products covering medical devices, US OTC drugs and other categories. Since its establishment, the company has always adhered to the service tenet of honest operation and customer first, the business philosophy of surviving by quality and serving customers wholeheartedly, and exceeding customer expectations has always been Enokon's perpetual pursuit!
Our production philosophy established from the very beginning: always regard patients as the ultimate customers.
Our development philosophy: we never do things that harm long-term interests for immediate gains, and all our actions are based on future development. When immediate interests conflict with long-term interests, we will resolutely abandon immediate interests to safeguard long-term ones. We deeply understand that our development is built on the healthy growth and sustainable development of our customers. Therefore, we have always adhered to the business philosophy of honest operation, serving customers wholeheartedly and developing together with customers, which is also the foundation of our success.
