# FDA WARNING_LETTER - wellmill llc/ - May 30, 2014

Source: https://www.keypedia.com/records/warning_letter/wellmill-llc/02cdafdd-ba31-4412-957d-13e71f22d7c9

> FDA WARNING_LETTER for wellmill llc/ on May 30, 2014. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: wellmill llc/
- Inspection Date: 2014-05-30
- Product Type: Food
- Office Name: New York District Office
- Summary: 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.

## Related Officers

- [Kristen C. Jackson](https://www.keypedia.com/people/kristen-c-jackson/9d19b70c-6db1-4249-8372-f2140f326c9a)
- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/wellmill-llc/14ea383c-feb9-4cb7-bf46-c3a18869bc87

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d