FDA WARNING_LETTER - WellnessOne World, LLC - June 09, 2011

An FDA inspection of WellnessOne World, LLC's dietary supplement manufacturing facility on June 7-9, 2011, revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplement products adulterated. The firm failed to qualify suppliers of non-dietary components by confirming certificate of analysis results and maintaining documentation, as required by 21 CFR 111.75(a)(2)(ii)(A) and (C). Additionally, the company did not prepare and follow written Master Manufacturing Records (MMRs) for each unique product formulation and batch size (21 CFR 111.205(a)). Furthermore, WellnessOne World lacked established and followed written procedures for reviewing and investigating product complaints and maintaining related records (21 CFR 111.553, 111.560, 111.570). Beyond CGMP issues, a review of product labeling and the company website in November 2011 found that products like ProOneZyme, FlaxOne, OneZyme, OnlyOneGold, and OneBalance are promoted with therapeutic claims for disease treatment, prevention, or mitigation. These claims cause the products to be unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act, requiring prior FDA approval (section 505(a)). Moreover, these products are misbranded under section 502(f)(1) of the Act because adequate directions for use cannot be written for laypersons given their intended conditions. The FDA requires a written response within 15 working days detailing corrective actions and preventative measures, with supporting documentation. Failure to comply may lead to regulatory actions such as seizure or injunction.