FDA WARNING_LETTER - Bhelliom Enterprises Corp - July 29, 2013

The FDA inspected Bhelliom Enterprises, Corp.'s dietary supplement facility from July 10-29, 2013, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplements adulterated. A May 2014 website review also revealed unapproved new drug and misbranding violations. Thermolene Body Sculptor and Alcohol-X Hangover Remedy are unapproved new drugs (section 201(p)) due to therapeutic claims, and Alcohol-X is misbranded (section 502(f)(1)) for lacking adequate directions for use. CGMP violations include failing to establish and follow written procedures for product complaints (21 CFR 111.553), quality control operations (21 CFR 111.103, 111.140(b)(1)), dietary supplement specifications (21 CFR 111.70), records for production/process control (21 CFR 111.180), returned dietary supplements (21 CFR 111.503), and holding/distribution operations (21 CFR 111.453). Several dietary supplements were also misbranded: Mr. Energy 8-HR Energy shot for a false label (section 403(a)(1)); Mr Energy 8-HR Energy Capsule, Vigor-EX Capsule, Thermolene capsules, and Growth-Rx caplets for failing to comply with 21 CFR 101.36 regarding ingredient listing; and Growth-Rx Dietary Supplement for incorrect ingredient order (21 CFR 101.36(b)(3)(i)) and incorrect serving size (section 403(q)(1)(A), 21 CFR 101.36(b)(1)). The firm must promptly correct all violations, prevent recurrence, and submit a written response with documentation within 15 working days. Failure to comply may result in enforcement actions like seizure or injunction, and re-inspection fees.