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  5. Empacadora Bilbo S.A. DBA Bilbosa - 675442 - 02/09/2024
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WARNING LETTER

Empacadora Bilbo S.A. DBA Bilbosa MARCS-CMS 675442 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
David Acebo
Recipient Title
Plant Manager
Empacadora Bilbo S.A. DBA Bilbosa

Ciudadela Monterrey
Carretera Manta - Montecristi Km 6. 5
Montecristi, Manabi
Ecuador

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

February 9, 2024

WARNING LETTER

Reference # 675442

Dear Mr. Acebo:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Empacadora Bilbo S.A. DBA Bilbosa, located at Ciudadela Monterrey, Carretera Manta - Montecristi Km 6. 5, Montecristi, Manabi, Ecuador on July 27-28, 2023. During the inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your responses, received via email on August 11, 2023 and October 13, 2023, which included a written statement of corrective actions and an updated HACCP plan. However, our evaluation of your responses revealed that you continue to have serious concerns with your HACCP program, as further described in this letter.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your frozen, raw, histamine-forming fish are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the June 2022 Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

Your significant deviations are as follows:

1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR 123.6(a) and (c)(2). A “critical control point” is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your HACCP plan for frozen raw fish including histamine-forming fish, dated August 8, 2023, does not list a critical control point at the “(b)(4)” step to control scombrotoxin (histamine) formation.

Since you may store received fish in a refrigerated cooler until processing, you should include storage of the fish as a critical control point to ensure that proper time and temperature controls are maintained to control histamine formation. Furthermore, you should ensure the fish are held at a cooler temperature of 40°F (4.4°C) or below; or the fish is completely and continuously surrounded by ice throughout the storage time.

2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your HACCP plan for frozen raw fish including histamine-forming fish, dated August 8, 2023, list monitoring procedures that are not adequate to control scombrotoxin (histamine) formation.

a. Your monitoring procedures at the “(b)(4) (CCP 01)” critical control point are not adequate to control scombrotoxin (histamine) formation. The monitoring procedures (i.e., “(b)(4)”) do not list the number of fish that will be analyzed for (i) histamine analysis, (ii) sensory examination, and (iii) internal temperature measurements to ensure that histamine will be adequately controlled at receiving. FDA recommends that the monitoring procedures include how many fish will be examined OR an explanation of how you determine a “representative number of fish” for every lot received.

b. Your monitoring procedure of visually checking the “(b)(4)” at the “(b)(4)” critical control point is not adequate to control C. botulinum growth and toxin formation. Your monitoring procedure should ensure the collection and examination of a representative number of labeled finished packages from each lot of products processed. Your firm places your frozen finished products in (b)(4) packed plastic bags, this introduces the hazard of C. botulinum when controls are not in place for safe handling. FDA recommends ensuring that the primary packages are labeled with safe handling instructions, such as “Important: Keep frozen until used – Thaw under refrigeration immediately before use.”

3. Because you chose to include corrective action plans in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for frozen raw fish including histamine-forming fish, dated August 8, 2023, at the following critical control points are not appropriate.

a. Your corrective action plans at the “(b)(4) (CCP 01)” critical control point plans are not adequate to address critical limit deviations for histamine analysis, sensory examination, and internal temperature measurement. The listed corrective action plans of “(b)(4)” do not state how you will correct the cause of the deviations for each of the critical limits.

b. Your corrective action plan at the “(b)(4)” critical control point does not address the cause of the deviation to prevent reoccurrence of the deviation. The listed corrective action plan of “(b)(4)” appears to be inadequate because it does not state how you will correct the cause of the critical limit deviation.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B).

You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the U.S. Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, Maryland 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Phillips via email at Sheena.Phillips@fda.hhs.gov. Please reference CMS # 675442 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition

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