FDA 21 CFR-111 Certified Botanical Supplements - Tested and Verified in the USA
It’s well established that test results from different labs, and different countries vary significantly. Yet, a majority of botanical supplements and extracts sold in the U.S. are never tested in this country by the suppliers that sell them! These products are shipped into contract warehouses, and shipped out to customers without any appropriate supply chain validation, sampling, or US testing.
ENI: A Certified Supply Chain,
From Field to Finished Product®
At ENI we believe there is a code of responsibility for importation and distribution of raw materials. Our high level FDA 21 CFR-111 level certification for our botanical extracts confirms that we stand behind that code with certified testing in the USA, as well as a fully transparent, audited supply chain.
FDA 21 CFR-111 Certification: What it means for you
No more surprises! Whether you package your product, or ship to a contract manufacturer there is no worse scenario than receiving material you can’t work with, or the costs of failed and returned finished goods. Today’s companies can’t afford to rest on testing done 6000 miles offshore. ENI provides FDA 21-CFR-111 certified testing here in the U.S., as your quality filter to production.
Our internal and outside laboratory-testing program provides the following range of QA testing:
In-House Testing Capabilities:
- NIR (Near Infrared): Basic ingredient identification
- UV/VIS: Potency testing on a range of active and marker compounds
- HPLC: Potency testing. Adulterant screening. Research and Development
- STABILITY CHAMBER: Accelerated and real time stability testing on ENI ingredients and formula blends
- MICROBIOLOGY: Micro testing on all ENI ingredients