FDA WARNING_LETTER - Optimum Bioenergy International Corp. - June 16, 2017

On December 21, 2017, the FDA issued a Warning Letter to Optimum Bioenergy, Intl. following an inspection of their Corona, CA facility from June 6-16, 2017. The inspection revealed serious violations of 21 CFR Part 111 (cGMP for dietary supplements), rendering their products adulterated under 21 U.S.C. § 342(g)(1). Additionally, EssenceLife Bee Propolis, Youth Life L-Carnitine, Youth Life Collagen, and Youth Life Calcium products were found to be misbranded under 21 U.S.C. § 343.

Key violations include: 1. Failure to establish and follow written procedures for quality control operations (21 CFR 111.103). 2. Failure to establish finished product specifications for identity, purity, strength, and composition (21 CFR 111.70(e)). 3. Failure to prepare batch production records for each batch manufactured (21 CFR 111.255(a)). 4. Failure to prepare and follow written master manufacturing records (21 CFR 111.205(a)). 5. Failure to establish written procedures for returned dietary supplements (21 CFR 111.503). 6. Failure to establish written procedures