# FDA WARNING_LETTER - Bradley Industries, Inc. - June 13, 2012

Source: https://www.keypedia.com/records/warning_letter/bradley-industries-inc/02f5d9e9-de80-4c1a-a650-fb7a65fcf1bf

> FDA WARNING_LETTER for Bradley Industries, Inc. on June 13, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bradley Industries, Inc.
- Inspection Date: 2012-06-13
- Product Type: Food
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Bradley Industries, Inc.'s manufacturing facility in Milwaukee, Wisconsin, on June 5, 12-13, 2012, revealed significant deviations from food labeling regulations (21 CFR Part 101). These violations cause their Stoneridge pasta products to be adulterated under section 402 and misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act).

Specific violations include:
1.  **Adulteration (Section 402(a)(2)(C)):** Stoneridge pasta products (Gourmet Fettuccine, Tri-Color Fettuccine, Basil & Tomato Linguine, Spinach Fettuccine, Garlic & Basil Pesto Linguine) are made from semolina enriched with folic acid. Folic acid is not permitted in semolina flour per 21 CFR 172.345(c), making it an unsafe food additive.
2.  **Misbranding - Allergen Declaration (Section 403(w)):** The labels for the aforementioned pasta products fail to declare wheat, a major food allergen, despite containing "100% Durum Semolina Flour Enriched" or "100% Organic Durum Flour." Labels must declare major food allergens as specified in Section 403(w)(1)(A) or (B) of the Act.
3.  **Mis

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/marie-a-fadden/2ad9f719-4467-46be-b9a9-d7d077268c5c)
- [Acting Assistant Commissioner](https://www.keypedia.com/people/michael-dutcher/5e9981f8-673f-4a2c-a0b5-dd5e8e8de1f4)

Company: https://www.keypedia.com/companies/bradley-industries-inc/4eb7ad5a-e620-4a0c-9783-4de00e2c85a7

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d