# FDA WARNING_LETTER - Inaudi Commerciale Srl - April 28, 2010

Source: https://www.keypedia.com/records/warning_letter/inaudi-commerciale-srl/f1656fec-af6a-4963-a4b5-cffb47d6d9b6

> FDA WARNING_LETTER for Inaudi Commerciale Srl on April 28, 2010. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Inaudi Commerciale Srl
- Inspection Date: 2010-04-28
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On April 26-28, 2010, the FDA inspected Inaudi Commerciale Srl. in Borgo San Dalmazzo, Italy, and found serious deviations from low-acid canned food regulations (21 CFR Parts 108 and 113). These failures render their canned truffles adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, as the product was prepared, packed, or held under insanitary conditions.

Significant violations included:
*   Lack of documentation for the scheduled process for canned sliced truffles, not established by qualified persons (21 CFR 113.83).
*   No heat distribution data to prove adequate air venting in retorts (21 CFR 113.40(a)(12)(iii)).
*   A Colussi retort lacked a mercury-in-glass thermometer or equivalent (21 CFR 113.40(a)(1)).
*   Failure to record processing and production information, including actual processing times and thermometer readings (21 CFR 113.100(a)(1)).
*   Failure to conduct and record routine can double seam teardown exams (21 CFR 113.60(a)(1)).

The firm's May 1, 2010, response was deemed inadequate as it proposed corrections

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/donald-w-greaves/7512ce2f-0f6d-4a06-acaf-7e825defa90d)
- [Senior Advisor at FDA](https://www.keypedia.com/people/jennifer-a-thomas/b73c3318-4fd8-46b2-bb12-591f54294659)

Company: https://www.keypedia.com/companies/inaudi-commerciale-srl/e042e9a5-a0ae-4a35-88ce-5e919c07c4cc

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2