# FDA WARNING_LETTER - Golden Gate Soy Food, Inc. - September 21, 2012

Source: https://www.keypedia.com/records/warning_letter/golden-gate-soy-food-inc/1faa4d1d-df53-48c8-b4db-fd382ebc07d5

> FDA WARNING_LETTER for Golden Gate Soy Food, Inc. on September 21, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Golden Gate Soy Food, Inc.
- Inspection Date: 2012-09-21
- Product Type: Food
- Office Name: Department of Health and Human Services
- Summary: On November 28, 2012, the FDA issued a Warning Letter to Golden Gate Soy Food, Inc. following an inspection from September 12-21, 2012. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their tofu and soy-based products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
- **Processes and Controls (21 CFR 110.80):** Employees used unsanitary water from a cold water bath containing non-food particles (metal, dirt, plastic) and a filthy 55-gallon drum with debris and stains for in-process and finished tofu.
- **Equipment and Utensil Maintenance (21 CFR 110.80(b)(1)):** Equipment (cold water bath, metal vat, soybean grinder, whey separator, buckets) had visible residues and debris even after cleaning and sanitation.
- **Equipment and Container Protection (21 CFR 110.80(b)(7)):** Aluminum trays for ready-to-eat product were stored on the floor, stained, and placed on a rusty cart, some soaked in cloudy water before use.
- **Personnel Hygiene (21 CFR 110.10(b)):** Employees

## Related Officers

- [Director ](https://www.keypedia.com/people/barbara-j-cassens/26dd2da1-417d-4913-9432-3d50fb3c2f40)

Company: https://www.keypedia.com/companies/golden-gate-soy-food-inc/0c864ff5-e251-48d7-8721-35e2e02dec9b

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861