# FDA WARNING_LETTER - Ito En (USA) Inc. - July 02, 2012

Source: https://www.keypedia.com/records/warning_letter/ito-en-usa-inc/da86e610-4814-4cda-b96e-2a845a1a2c89

> FDA WARNING_LETTER for Ito En (USA) Inc. on July 02, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ito En (USA) Inc.
- Inspection Date: 2012-07-02
- Product Type: Food
- Office Name: San Francisco District Office
- Summary: On November 2, 2012, the FDA issued a Warning Letter to Ito En (USA) Inc. following an inspection of their Honolulu, Hawaii low-acid canned food facility from June 25-28 and July 2, 2012. The inspection revealed serious deviations from low-acid canned food regulations (21 CFR Parts 108 and 113), which could lead to products being deemed adulterated under Sections 402(a)(3) and 402(a)(4) of the Act.

Key violations included:
1.  **Failure to adhere to scheduled processes (21 CFR 108.35(c)(3)(i)):** The firm's Iced Cappuccino and Green Tea products were processed with times shorter than the minimum process times filed with the FDA. The company's response indicated a review by their process authority and a plan to log deviations and hold affected products, which the FDA stated would be verified in a future inspection.
2.  **Failure to sanitize cooling water (21 CFR 113.60(b)):** Records showed no detectable chlorine in recirculated cooling water on multiple dates. The company's response outlined a plan for daily chlorinator checks but lacked documented evidence of implementation.
3.  **Failure to properly code containers (21 CFR 113.60(c)):**

## Related Officers

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

Company: https://www.keypedia.com/companies/ito-en-usa-inc/05f28624-15fc-4d12-bd77-ec13906473d0

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