FDA WARNING_LETTER - wellmill llc/ - May 30, 2014

The FDA inspected Wellmill LLC dba Vitamix, a dietary supplement manufacturing facility, from May 19-30, 2014, and found serious violations of CGMP regulations (21 CFR Part 111), rendering their products adulterated.

Key violations include: 1. **Inadequate Identity Testing (21 CFR 111.75(h)(1)):** The firm used organoleptic testing, which is not scientifically valid for powdered ingredients like Butcher's Broom and Lactobacillus Acidophilus. While the firm stated they use spectroscopy for 70% of raw materials, no documentation was provided, and a specific lot was released based only on organoleptic, heavy metal, and microbiological testing. The firm's proposed FT-NIR Spectrometer for all incoming raw materials is noted, but near-IR spectroscopy is deemed inadequate for complex proteins or bacteria. 2. **Failure to Maintain Laboratory Records (21 CFR 111.325(b)(2)(ii)):** The firm failed to provide documentation of spectroscopy testing results for raw material identity during the inspection. 3. **Insufficient Finished Product Testing (21 CFR 111.75(c)(2)):** The firm relied on microbial and organoleptic testing and production input to verify finished product specifications. Organoleptic testing is insufficient for multi-component products, and microbial testing does not verify identity.