Frequently Asked Questions
Do you manufacture for international (non U.S.) customers?
Yes. We are very experienced with international registration requirements and have registered products in several major international markets.
Are you registered with the FDA? What are your GMP certifications?
We are registered with the FDA and follow Good Manufacturing Practices (GMPs) in accordance with 21 CFR 111.
We are third-party audited by NSF for compliance to GMPs (view our registration with NSF). Additionally, we welcome our customers to conduct audits of our facility and processes, which many of them do on a recurring basis.
Can I visit your facility?
Yes, tours are available for prospective customers and must be scheduled several weeks in advance to account for our manufacturing schedule.
Do you test your products in-house?
We perform in-house testing on incoming raw materials in accordance with GMPs. Finished product testing is conducted at third-party labs whose protocols have been validated by our QC team. We work with Covance, Eurofins, Advanced Labs, among others.
Do you do “toll manufacturing?"
To us toll manufacturing is a situation where two conditions are met:
a) the formula is simple, straightforward, and we are confident it will not require our R&D in order to run successfully at scale
b) the customers supplies all raw materials to us
We evaluate these on a case-by-case basis and based largely on our manufacturing schedule.
However all ingredients that come through our facility still proceed through our rigorous QC process, along with the finished product. This emphasis on quality often results in slightly higher prices. As a result, there are sometimes more cost-effective options from providers who are setup for toll manufacturing by design.