FDA WARNING_LETTER - LiquidCapsule Manufacturing, LLC - October 20, 2014

On May 15, 2015, the FDA issued a Warning Letter to LiquidCapsule Manufacturing, LLC and Health International Products, Inc. following an inspection from September 22 to October 20, 2014. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), causing their EnergyXcentric products to be adulterated. Additionally, the products were found to be misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to establish component specifications for purity and strength (21 CFR 111.70(b)(2)), specifically for caffeine pellets and conjugated linoleic acid used in EnergyXcentric. 2. Failure to maintain documentation for qualifying suppliers of non-dietary ingredients, including confirmation of supplier Certificate of Analysis results (21 CFR 111.75(a)(2)(ii)(C)). 3. Failure to establish complete product specifications for identity, purity, strength, and composition of finished batches (21 CFR 111.70(e)). 4. Quality control personnel failed to reject dietary supplements that did not meet specifications, specifically regarding Vitamin B12 strength in EnergyXcentric lots (21 CFR 111.75(a)(2)(ii)(E)).