FDA Finds Unigen's Facility GMP Compliant

SEATTLEUnigen Inc.'s ingredient manufacturing facility in Byeongcheon, South Korea, successfully passed FDA's cGMP (current good manufacturing practice) inspection.   The two-day audit took place in April 2012, and FDA did not issue any Form 483 observations. FDA issues Form 483s for GMP violations.

The facility, which manufactures Unigens dietary supplement ingredients, was also inspected and certified by Korea FDA for food GMP.

Unigen develops and manufactures proprietary natural-product active ingredients for dietary supplements, functional foods, cosmetic and personal care products, and prescription medical food and botanical drug products.  Earlier this year, a study found Unigen's Univestin, made from bioflavonoids derived from standardized extracts from the roots of Scutellaria baicalensis and the heartwood of Acacia catechu, combated pain in osteoarthritis (OA) sufferers just as well as a non-steroidal anti-inflammatory drug (NSAID).