EnviroZyme® Is Now FDA Registered for Human Food and Animal Feed Probiotic Fermentation

EnviroZyme® Is Now FDA Registered for Human Food and Animal Feed Probiotic Fermentation

November 16, 2020

The U.S. Food and Drug Administration (FDA) has accepted registration of EnviroZyme's new state-of-the-art manufacturing facility in Bowling Green, OH, for the fermentation of probiotics for human consumption in food, as well as additives for animal feed.

Since inception, EnviroZyme has voluntarily complied with Current Good Manufacturing Practices (cGMP)—which are regulated by the FDA—ensuring every process is properly documented, designed, monitored, and controlled. Because the base manufacturing standards already in place at the facility were extremely high, the increased scrutiny accompanied by obtainment of FDA registration is yet another way to demonstrate commitment to quality, reliability, and safety.

“We already hold ourselves to the highest possible standards, so the procedures and quality management principles that guide us daily really haven’t changed.” said John Ross, Vice President of Sales. “We acquired this registration to further assure our customers and open doors to new business.”

FDA registration means that EnviroZyme has implemented identification and effective prevention of potential hazards regarding the human food and animal feed products being made, as well as strict adherence to FDA guidelines for their fermentation, package, and shipment. The FDA will also be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

EnviroZyme has built one of the industry's most technologically advanced microbial manufacturing plants in the U.S., and in addition to FDA registration and cGMP compliance, it is also ISO 9001:2015 certified. Within it, exceptional team members who are committed to exceptional science serve as the cornerstones for success.

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