FDA WARNING_LETTER - ultimate formulations, inc. - April 02, 2010

On March 17-April 2, 2010, the FDA inspected Ultimate Formulations, Inc., dba Best Formulations, finding significant cGMP violations (21 CFR Part 111) for dietary supplements, rendering products adulterated under Section 402(g)(1) of the Act.

Key violations include: 1. **Failure to Determine Product Specifications (21 CFR 111.73, 111.75(c)):** The firm did not test every finished batch for strength or composition for numerous softgel, tablet, capsule, powder, and tea products. The company's proposed "Quality Agreement" shifting responsibility to customers and testing only two random lots annually was deemed inadequate, as the manufacturer is solely responsible for ensuring specifications are met. 2. **Inadequate Master Manufacturing Records (MMR) (21 CFR 111.205(b)(1), 111.205(b)(2), 111.210(h)):** MMRs for several products lacked specifications for critical control points, failed to establish controls to ensure specifications were met, and omitted required written instructions for manufacturing processes, including corrective action plans for out-of-specification (OOS) results (e.g., selenium levels, size/shape deviations). The firm's proposed "notify Supervisor" instruction was insufficient. 3