# FDA WARNING_LETTER - Empacadora Bilbo S.A. DBA Bilbosa - July 28, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/empacadora-bilbo-sa-dba-bilbosa/a48e27ae-ed92-493a-96d3-06064fde9630

> FDA WARNING_LETTER for Empacadora Bilbo S.A. DBA Bilbosa on July 28, 2023. Product: Other. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Empacadora Bilbo S.A. DBA Bilbosa
- Inspection Date: 2023-07-28
- Product Type: Other
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On February 9, 2024, the FDA issued a Warning Letter to Empacadora Bilbo S.A. DBA Bilbosa following an inspection on July 27-28, 2023, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The FDA acknowledged the firm's responses from August 11 and October 13, 2023, but found continued serious concerns.

The primary violation is that the firm's frozen, raw, histamine-forming fish are adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, as they were prepared, packed, or held under injurious conditions.

Specific deviations include:
1.  **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for frozen raw fish, dated August 8, 2023, lacks a critical control point at the "(b)(4)" step to control scombrotoxin (histamine) formation, particularly for refrigerated storage. The FDA recommends maintaining fish at 40°F (4.4°C) or below, or continuously surrounded by ice.
2.  **Inadequate Monitoring Procedures (21 CFR 123.6(c

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)

Company: https://www.globalkeysolutions.net/companies/empacadora-bilbo-sa-dba-bilbosa/da75d9b1-069e-402b-b70f-bf3a985b28a2

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