# FDA 483 - Nature Pure LLC - February 16, 2011

Source: https://www.keypedia.com/records/483/nature-pure-llc/f93833d9-7bf3-4a5e-8c87-3b30fb7e932c

> FDA 483 for Nature Pure LLC on February 16, 2011. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nature Pure LLC
- Inspection Date: 2011-02-16
- Product Type: Food
- Office Name: Cincinnati District Office
- Summary: On February 16, 2011, the FDA issued a Form 483 to Nature Pure LLC, an egg grower located at 26560 Storms Rd, West Mansfield, OH 43358-9662, following an inspection conducted from February 7 to February 16, 2011. The report was issued to Scott A. Culwell, Vice President of Operations.

The inspection revealed three observations related to Salmonella Enteritidis (SE) prevention.

Observation 1 noted that environmental samples for SE detection were not tested using the "Environmental Sampling and Detection of Salmonella in Poultry Houses" method, or an equivalent method in accuracy, precision, and sensitivity. The lab utilized a different method, and no scientific data was provided to prove its equivalency.

Observation 2 detailed that pullet environments were not tested for SE when pullets were 14 to 16 weeks of age. Specifically, pullets at Farm 1, pullet house (b)(4), were sampled at approximately 12 weeks and two days of age, not within the required timeframe. Additionally, pullets at Farm 1, pullet house (b)(4), were not tested for SE at all before depopulation.

Observation 3 indicated that the firm's written SE prevention plan lacked appropriate measures. The plan stated pullet houses were to be sampled at 10 to 1

## Related Documents

- [483 - 2011-03-02](https://www.keypedia.com/records/483/nature-pure-llc/7ff0d468-13ac-4f14-9cb0-a0ae5cd6bc31)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/michael-e-campbell/977206b0-ed60-4192-af2e-1fe8a20a271e)

Company: https://www.keypedia.com/companies/nature-pure-llc/dd444407-a547-4544-9df3-a34d745ed683

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22