# FDA WARNING_LETTER - Empacadora Diamante S.A. - April 04, 2013

Source: https://www.keypedia.com/records/warning_letter/empacadora-diamante-sa/0fc7e89d-2a60-434e-9163-914b3d11c18b

> FDA WARNING_LETTER for Empacadora Diamante S.A. on April 04, 2013. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Empacadora Diamante S.A.
- Inspection Date: 2013-04-04
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On April 3-4, 2013, the FDA inspected Empacadora Diamante S.A. in Ecuador and found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's histamine-forming fish products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
1.  **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The revised HACCP plan for scombrotoxin-forming fish lacked critical control points (CCPs) for post-processing storage and for processing steps (eviscerating, cutting, cleaning, classifying) to control histamine formation.
2.  **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** At the receiving CCP, critical limits for decomposition (more than 2 fish in a 118-fish sample showing decomposition) and internal temperature (40°F/4.4°C or below for fish held iced 24+ hours after death) were not adequate.
3.  **Missing Monitoring Procedures/Frequency (21 CFR 123.6(c)(4)):** The HACCP plan lacked monitoring procedures and frequency for a specific critical limit at a CCP related

## Related Officers

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

Company: https://www.keypedia.com/companies/empacadora-diamante-sa/94e3eb68-4cf8-4e87-a5b1-884dcc1305f2

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