# FDA WARNING_LETTER - Accelerated Freeze Drying Co. Ltd. - December 13, 2013

Source: https://www.keypedia.com/records/warning_letter/accelerated-freeze-drying-co-ltd/a240eacc-4012-42d5-8b75-50c6c7d4b245

> FDA WARNING_LETTER for Accelerated Freeze Drying Co. Ltd. on December 13, 2013. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Accelerated Freeze Drying Co. Ltd.
- Inspection Date: 2013-12-13
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On June 2, 2014, the FDA issued a Warning Letter to Accelerated Freeze Drying Co. Ltd. following an inspection from December 12-13, 2013, which revealed violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's freeze-dried shrimp products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The primary violations include:
1.  **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The revised HACCP plan for "(b)(4)" freeze-dried shrimp lacks critical control points (CCPs) for pathogen growth and toxin formation. Specifically, it fails to include CCPs for processing phases III-V, where temperatures are between (b)(4), and cumulative exposure times should be limited to 1 hour above 26.7°C. Additionally, a CCP for "(b)(4)" the product in the IQF tunnel before entering the "(b)(4)" is missing, which is crucial for achieving the required moisture content.
2.  **Inadequate Critical Limits (21 CFR 123.6(c)(3)):**
    *   The critical limit of "(b)(4)" at the "Batch Cooking

## Related Officers

- [Deputy Office Director](https://www.keypedia.com/people/amy-a-barringer/04895ca2-f898-42c1-81e4-4c3ceaf70f9d)

Company: https://www.keypedia.com/companies/accelerated-freeze-drying-co-ltd/3edac61d-f2e8-4f63-9462-12e1628f5f0f

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