# FDA WARNING_LETTER - Keum Han Industrial Co. - February 18, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/keum-han-industrial-co/85cf49f6-3823-489c-87a3-32f8ab5c91ff

> FDA WARNING_LETTER for Keum Han Industrial Co. on February 18, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Keum Han Industrial Co.
- Inspection Date: 2020-02-18
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On February 17-18, 2020, the FDA inspected Kyung Eun Kim's seafood processing facility in Gangwon-do, South Korea, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's ready-to-eat (RTE) dried squid products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
1.  **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1))**: The revised HACCP plan for butter-flavored and bulgogi-flavored dried squid products (dated February 28, 2020) failed to list undeclared allergens (dairy and soy) as a reasonably likely food safety hazard.
2.  **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2))**: HACCP plans for RTE dried squid products (seasoned, butter-flavored, and bulgogi-flavored) lacked critical control points for unrefrigerated processing, where products are exposed for approximately (b)(4) hours. The FDA recommends processing at 40°F (4.4°C) or below, or limiting unrefrigerated steps to 2 hours when temperatures exceed 7

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.globalkeysolutions.net/companies/keum-han-industrial-co/ae13e6b2-69c7-4a08-b0ca-d727f484cd3b

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