Our production facility is located in Taiwan and therefore operate under Taiwan FDA regulations, which is a member of the PICS/GMP participating authorities. In order to serve the global market, we have scheduled to fulfill ISO 13485:2016 compliance for medical device in mid 2019, and will step towards compliance with the FDA cGMP article 21 CFR Part 820 in 2020.
In Albcura, the quality objectives are routinely discussed throughout the company. We have set up rigorous standards for raw material control and have established plural sourcing on critical materials.
If an audit or on-site audit is required, please Contact Us to discuss more details.