ColdStar's plant is audit-ready, with efficient, high-quality equipment that is operated according to industry-leading quality standards and certifications. That's where our most valuable asset comes in — our employees. It's up to them to ensure that your products are continually stewarded at the highest levels. So we focus on improving their core competency in every way possible.
Operating under an ISO13485 system and FDA guidelines are norms at ColdStar. These norms are only the starting point. We consistently exceed them with our own, more stringent quality standards.
ColdStar's ISO13485 registration gives you the ultimate peace of mind that as your co-manufacturer, we're always ready to exceed your quality expectations.
With ColdStar's documentation, what you see is what you get. Our personnel are required to document that all practices have been undertaken on schedule. In addition, practices that apply to specific processing runs are logged as part of that run's customer record.
Our diligence in following through on these detailed procedures ensures the quality and safety of the products we deliver to our clients. It requires investment and an unwavering commitment that may be above the norm, but for ColdStar, it's the only way we'll conduct business.