# FDA WARNING_LETTER - Tofu Yu, LLC - October 25, 2016

Source: https://www.globalkeysolutions.net/records/warning_letter/tofu-yu-llc/826c476d-dcd5-4a5a-8c2f-fb13d0f0963c

> FDA WARNING_LETTER for Tofu Yu, LLC on October 25, 2016. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Tofu Yu, LLC
- Inspection Date: 2016-10-25
- Product Type: Food
- Office Name: San Francisco District Office
- Summary: On December 22, 2016, the FDA issued a Warning Letter to Tofu Yu, LLC, following an inspection from October 11-25, 2016. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their ready-to-eat tofu and tofu products, including tofu veggie wraps, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included:
1.  **Improper Maintenance of Equipment and Utensils (21 CFR 110.80(b)(1)):** Investigators observed discolored and dirty equipment, including a coagulant pitcher, tofu shape-maker, tofu press plate, rice tortilla making equipment, and a wooden cutting board, all with dried residues.
2.  **Contamination from Production Procedures (21 CFR 110.80):** Uncovered tofu products in a walk-in cooler were stored directly beneath a dripping condensate from the cooler fan unit.
3.  **Pest Control Deficiencies (21 CFR 110.35(c)):** Approximately 30 live flying insects were observed in the tofu manufacturing area, perching on walls, a hose above equipment, and contacting processing equipment, including a soybean soaking barrel and conveyor belt. Similar issues were noted in previous

## Related Officers

- [Kathleen M. Lewis](https://www.globalkeysolutions.net/people/kathleen-m-lewis/c7f66b1a-d346-48cc-ab84-9ea6c2805268)

Company: https://www.globalkeysolutions.net/companies/tofu-yu-llc/49fe92ba-e58d-4799-abf4-408d14de3276

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df