On April 7, 2023, a group of 3 experts from FDA’s Winchester Engineering and Analytical Center (WEAC) conducted an on-site routine inspection at GCC to ensure that all GCC lasers sold to the United States comply with all the FDA safety regulations.
Together with the participation of GCC’s R&D and QC team, each step of the production process and QC workflow were disclosed and checked including raw material acceptance, production process management, finished product packaging & labeling, finished product storage & delivery, and finally the customer relations.
The FDA is a federal government agency under the U.S. Department of Health and Human Services. Its main responsibility is to oversee, certify, and regulate the comprehensive quality of domestically produced and imported food, drugs, biologics, cosmetics, and medical devices into the United States to ensure that these manufacturing facilities comply with U.S. food regulations. The WEAC laboratory is the only FDA facility capable of providing both specialized analytical services in medical device and radionuclide analysis. WEAC engineers and scientists perform foreign inspections for a variety of consumer electronic products including lasers, microwave ovens, and sun tanning devices.
Under the guidance and training from FDA’s experts, GCC will further optimize our design, label, and packaging to secure the safety of GCC lasers' users.