FDA WARNING_LETTER - Ceba-Tek, Inc. - February 05, 2019

The FDA inspected Ceba-Tek Inc. from January 30 to February 5, 2019, identifying serious violations of 21 CFR Part 111, Current Good Manufacturing Practice (cGMP) for dietary supplements. These violations render the firm's products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. Additionally, the Desert Harvest Magnesium with Super-Strength Aloe Vera product was found to be misbranded under section 403 of the Act.

Key cGMP violations included failure to establish specifications for manufacturing processes, components, and finished products (21 CFR 111.70), and failure to qualify suppliers for non-dietary ingredients by confirming Certificate of Analysis reliability and maintaining documentation (21 CFR 111.75(a)(2)(ii)(A), (C)). These were noted as repeat observations from previous inspections. Further deficiencies involved not preparing written Master Manufacturing Records for each unique formulation and batch size (21 CFR 111.205(a)), lacking adequate documentation for in-process specifications (21 CFR 111.70(c)(2)), and incomplete Batch Production Records (21 CFR 111.255(b), 111.260).

Misbranding issues for the Desert Harvest Magnesium product included a false "100% cGMP compliant" claim (403(a)(1)), missing complete place of business information (403(e)(1), 21 CFR 101.5), undeclared ingredients (403(i)(2), 21 CFR 101.4), and failure to identify the plant part for botanical ingredients (403(s)(2)(C), 21 CFR 101.4(h)(1)).

The firm's written responses to the inspectional observations were deemed inadequate. Ceba-Tek Inc. must promptly correct all cited violations, provide a written response within fifteen working days detailing corrective actions and supporting documentation, and prevent recurrence. Failure to comply may lead to legal action, including seizure and injunction, and re-inspection fees. The FDA also noted concerns regarding an in-process CBD/Hemp product.