FDA WARNING_LETTER - Botanic Oil Innovations, Inc. - April 28, 2011

On April 26-28, 2011, the FDA inspected Botanic Oil Innovations, Inc. in Spooner, WI, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under 21 U.S.C. § 342(g)(1).

Key CGMP violations include: 1. Failure to establish product specifications for identity, purity, strength, composition, and contamination limits (21 CFR 111.70(e)). 2. Failure to prepare and follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)). 3. Failure to establish and keep records of component specifications (21 CFR 111.70(b)(1), (b)(2), 111.95(b)(1)). 4. Quality control operations failing to review and approve batch production records, and lack of documentation for such reviews (21 CFR 111.123(a)(2), 111.140(b)(2)). 5. Failure to qualify suppliers of components by confirming certificate of analysis results (21 CFR 111.75(a)(2)(A)). 6.