# FDA WARNING_LETTER - Shinhan F&B; Co., Ltd. - May 11, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/shinhan-fb-co-ltd/6109a096-bfec-4f0a-a1bc-daddf8819617

> FDA WARNING_LETTER for Shinhan F&B; Co., Ltd. on May 11, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Shinhan F&B; Co., Ltd.
- Inspection Date: 2012-05-11
- Product Type: Food
- Office Name: Department of Health and Human Services
- Summary: On November 2, 2012, the FDA issued a Warning Letter to Shinhan F&B Co., Ltd. following an inspection on May 10-11, 2012, which revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's frozen vacuum-packaged roasted squid products were deemed adulterated under 21 USC 342(a)(4) due to preparation, packing, or holding conditions that may render them injurious to health.

Key violations include:
1.  **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for frozen vacuum-packaged roasted squid failed to list *Clostridium botulinum* growth and toxin formation as a reasonably likely food safety hazard, despite vacuum packaging creating anaerobic conditions conducive to its growth.
2.  **Missing Critical Control Point (21 CFR 123.6(a) and (c)(2)):** The HACCP plan did not include a critical control point for cooling to control pathogen growth from post-process contamination after cooking.
3.  **Insufficient Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan lacked adequate critical limits at the cooking critical control point to control *Listeria monocytogenes*. The

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/michael-w-roosevelt/136906d6-8e93-4080-acf9-5d48d4509a80)

Company: https://www.globalkeysolutions.net/companies/shinhan-fb-co-ltd/1e72a4a0-e6a4-4cee-93f2-9a5030e2aa34

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